# QbD Group

> QbD Group is a life sciences consulting firm (600+ experts, founded 2012 in Belgium) that guides
> pharmaceutical, biotech, medical device, IVD and combination product companies from idea to patient
> across regulatory affairs, quality assurance, clinical operations, pharmacovigilance, toxicology,
> laboratory services and software/computer system compliance.

## Facts

- Website: https://qbdgroup.com
- Legal name: QbD Group NV
- Founded: 2012, Belgium
- Headquarters: Groenenborgerlaan 16, 2610 Wilrijk, Belgium
- Team: 600+ life sciences consultants
- Regions served: Europe (BE, NL, ES, PT, DE, CH, SE), United States, Asia
- Industries: pharmaceuticals, biotech, ATMP, medical devices, IVD, combination products, companion diagnostics, cosmetics, food supplements
- Regulatory frameworks covered: EU MDR 2017/745, EU IVDR 2017/746, FDA QMSR, ISO 13485, ISO 14971, GxP (GMP/GCP/GVP/GLP), EU Annex 1, ICH guidelines, EU AI Act, GAMP 5, 21 CFR Part 11
- Languages: English (/en), Spanish (/es), Simplified Chinese (/zh-cn)
- Contact: +32 3 844 45 01 — https://qbdgroup.com/en/contact
- LinkedIn: https://www.linkedin.com/company/qbd-group

## Key Pages

- [Home](https://qbdgroup.com/en): Life sciences consulting overview.
- [Services](https://qbdgroup.com/en/services): Regulatory, quality, clinical, PV, tox, lab and software services.
- [Solutions](https://qbdgroup.com/en/solutions): Strategic programmes across the product lifecycle.
- [Industries](https://qbdgroup.com/en/industries): Sector-specific expertise (pharma, medtech, IVD, ATMP).
- [About QbD Group](https://qbdgroup.com/en/about-qbd): Company, mission, leadership, offices.
- [Our Team](https://qbdgroup.com/en/team): Named experts and their specialisms.
- [Certifications](https://qbdgroup.com/en/certifications): Accreditations and quality certifications.
- [Knowledge Center](https://qbdgroup.com/en/knowledge-center): All published expertise.
- [Regulatory Glossary](https://qbdgroup.com/en/knowledge-center/glossary): Definitions of life sciences regulatory terms.
- [Blog](https://qbdgroup.com/en/blog): Expert articles.
- [Regulatory Updates](https://qbdgroup.com/en/regulatory-updates): Analysis of regulatory change.
- [White Papers](https://qbdgroup.com/en/whitepapers): In-depth technical guides.
- [Case Studies](https://qbdgroup.com/en/case-studies): Client outcomes.
- [Webinars](https://qbdgroup.com/en/webinars): Live and on-demand sessions.
- [Events](https://qbdgroup.com/en/events): Conferences and summits.
- [Company News](https://qbdgroup.com/en/news): Announcements.
- [Contact](https://qbdgroup.com/en/contact): Talk to an expert.

## Localized Entry Points

- Spanish: [Inicio](https://qbdgroup.com/es), [Servicios](https://qbdgroup.com/es/servicios), [Industrias](https://qbdgroup.com/es/industrias), [Blog](https://qbdgroup.com/es/blog), [Glosario](https://qbdgroup.com/es/recursos/glosario)
- Simplified Chinese: [首页](https://qbdgroup.com/zh-cn), [服务](https://qbdgroup.com/zh-cn/services), [行业](https://qbdgroup.com/zh-cn/industries), [博客](https://qbdgroup.com/zh-cn/blog)

## Solutions

- [Market Entry into Europe for Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech/landing-in-europe)
  End-to-end regulatory, quality, and market access support for pharmaceutical and biotech companies entering the European market.
- [Emerging Biotech](https://qbdgroup.com/en/industries/pharma-biotech/emerging-biotech)
  Dedicated regulatory, CMC, clinical, and quality support for emerging biotech companies developing novel therapies.
- [Manufacturing Quality & Compliance](https://qbdgroup.com/en/industries/pharma-biotech/manufacturing-quality-compliance)
  GMP compliance, quality systems, and manufacturing excellence for pharmaceutical production and aseptic manufacturing.
- [Life Cycle Management for Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech/life-cycle-management)
  End-to-end product lifecycle support including CMC variations, pharmacovigilance, batch release, and post-market surveillance.
- [Market Entry into Europe for MedTech](https://qbdgroup.com/en/industries/medical-devices/your-medtech-gateway-to-europe)
  CE marking, MDR/IVDR compliance, and market access support for medical device and IVD companies entering Europe.
- [Emerging MedTech](https://qbdgroup.com/en/industries/medical-devices/startups)
  Regulatory, quality, and clinical support for MedTech startups and scale-ups bringing innovative devices to market.
- [Medical Device Software](https://qbdgroup.com/en/industries/medical-devices/medical-device-software)
  MDSW qualification, classification, IEC 62304 compliance, cybersecurity, and AI Act support for medical device software.
- [Life Cycle Management for Medical Devices and Diagnostics](https://qbdgroup.com/en/industries/medical-devices/life-cycle-management)
  Post-market surveillance, design change management, technical file maintenance, and re-certification under MDR/IVDR.
- [PrecisionDx (CDx)](https://qbdgroup.com/en/industries/companion-diagnostics)
  End-to-end companion diagnostics and precision medicine expertise, synchronizing Pharma and IVD workstreams.
- [Combination Products](https://qbdgroup.com/en/industries/combination-products)
  Navigating EU and US regulatory pathways for drug-device and biologic-device combination products.

## Services

- [RA Strategy for Pharma](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-strategy-pharma)
  Bringing your pharmaceuticals to the market requires a tailor-made strategy. We can help you to form that strategy and make it a success.
- [Commissioning](https://qbdgroup.com/en/services/qualification-validation/commissioning)
  Commissioning is crucial for getting your systems and equipment to perform at their best and safest. QbD Group is the expert in making sure your systems, utilities, facilities and equipment are up and
- [Clinical Trial Operations](https://qbdgroup.com/en/services/clinical-solutions/clinical-study-operations)
  Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.
- [QPPV / Local Representative](https://qbdgroup.com/en/services/pharmacovigilance/qppv-local-representative)
  Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.
- [PDE-OEL Reports](https://qbdgroup.com/en/services/toxicology/pde-oel-reports)
  We have a professional team of expert toxicologists to calculate the PDE value of any API and we offer the largest online library of high quality PDE reports.
- [QMS Implementation](https://qbdgroup.com/en/services/quality-assurance/qms-setup)
  Optimize your quality management system with QbD's tailored QMS Setup services. Build a smart, scalable system that aligns with regulatory standards and drives value.
- [Operational Software Compliance](https://qbdgroup.com/en/services/software-solutions-services/operational-software-compliance)
  Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability.
- [QC Chemical Analysis](https://qbdgroup.com/en/services/lab-services/chemical-analysis)
  Our GP certified QC laboratory can support your analytical needs from pharmacopoeial analysis of raw materials, active pharmaceutical ingredients (APIs), and investigational medicinal products (IMPs) 
- [ICSR Management](https://qbdgroup.com/en/services/pharmacovigilance/icsr-management)
  Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical trials and marketed products.
- [Medical Writing for Medical Devices](https://qbdgroup.com/en/services/clinical-solutions/medical-writing-for-medical-devices)
  Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval.
- [QMS Remediation & Support](https://qbdgroup.com/en/services/quality-assurance/qms-remediation-support)
  Achieve operational excellence with QbD's QMS Remediation & Support services. Address gaps, sustain certification, and maintain smooth operations seamlessly.
- [Drug Development](https://qbdgroup.com/en/services/regulatory-affairs/drug-development)
  New pharmaceuticals must be manufactured to high-quality standards before they can be placed on the market. We support you from drug discovery to pre-clinical and clinical testing.
- [Facility Qualification](https://qbdgroup.com/en/services/qualification-validation/facility-qualification)
  Confirm that your facilities and HVAC, cleanrooms, and monitoring systems, meet predetermined specifications and regulatory requirements.
- [Method Development](https://qbdgroup.com/en/services/lab-services/method-development)
  Method development and validation are essential to the drug development process to ensure the methods are well-defined and fit-for-purpose, and the results are robust and reliable.
- [Nitrosamine Risk Assessment](https://qbdgroup.com/en/services/toxicology/nitrosamine-risk-assessment)
  Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements.
- [Digitalization](https://qbdgroup.com/en/services/software-solutions-services/digitalization)
  Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions.
- [Utility Qualification](https://qbdgroup.com/en/services/qualification-validation/utility-qualification)
  Identify and mitigate risks associated with facility and utility failures such as water systems (WFI, ROW…), gas systems and distribution networks.
- [Method Validation](https://qbdgroup.com/en/services/lab-services/method-validation)
  To ensure that the methods meet regulatory requirements, we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidelines in combination with client-specific protocols.
- [QA Outsourcing](https://qbdgroup.com/en/services/quality-assurance/outsourced-qa)
  Simplify compliance and reduce costs with QbD Group's Outsourced QA solutions. Tailored support to manage your QMS or specific quality functions effectively.
- [Early Development](https://qbdgroup.com/en/services/regulatory-affairs/early-development)
  We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials.
- [Extractables & Leachables Reports](https://qbdgroup.com/en/services/toxicology/extractables-leachables-reports)
  Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise.
- [Pharmacovigilance & Certified Blended Training](https://qbdgroup.com/en/services/pharmacovigilance/pharmacovigilance-certified-blended-training)
  Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence.
- [Medical Device Software Compliance](https://qbdgroup.com/en/services/software-solutions-services/medical-device-software-compliance)
  Our service offers a tailor-made framework for medical device software compliance, ensuring adherence to MDR, IVDR, ISO13485, and other key standards.
- [Clinical Regulatory Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-regulatory-services)
  We help our sponsors conduct their clinical studies in Europe and beyond by expertly navigating both EU MDR and FDA pathways. Our regulatory guidance streamlines the approval process and supports fast
- [AI/ML Compliance](https://qbdgroup.com/en/services/software-solutions-services/ai-ml-compliance)
  Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and regulations.
- [Equipment Qualification](https://qbdgroup.com/en/services/qualification-validation/equipment-qualification)
  Ensuring that machinery, instruments, or systems used in production, testing, or any other processes consistently perform as intended.
- [Environmental Risk Assessment (ERA)](https://qbdgroup.com/en/services/toxicology/environmental-risk-assessment-era)
  Assess the environmental profile of your pharmaceutical products with our detailed report. Identify and mitigate the environmental risks.
- [Experts in IVD Clinical Performance Studies](https://qbdgroup.com/en/services/clinical-solutions/ivd-clinical-performance-studies)
  Do you need compliant clinical evidence for your IVD device? Our IVD experts are happy to support you in your IVD Performance Evaluation Studies.
- [Stability Studies](https://qbdgroup.com/en/services/lab-services/stability-studies)
  Investigating the stability and shelf-life of a finished product is an important area of expertise at QbD Group's Lab Services. We can help you determine the best approach for investigating the stabil
- [Qualified Person (QP) & Responsible Person (RP)](https://qbdgroup.com/en/services/quality-assurance/qualified-person-qp-responsible-person-rp)
  Meet regulatory requirements with QbD Group's QP/RP services. Rely on expert support for batch release, GMP/GDP compliance, and operational continuity.
- [Scientific Advice](https://qbdgroup.com/en/services/regulatory-affairs/scientific-advice)
  Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required health agencies.
- [Safety Reporting & Signal Detection](https://qbdgroup.com/en/services/pharmacovigilance/aggregate-safety-reporting)
  Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety.
- [Data Governance](https://qbdgroup.com/en/services/software-solutions-services/data-governance)
  QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market.
- [Annual Product Review (APR) & Product Quality Review (PQR)](https://qbdgroup.com/en/services/quality-assurance/annual-product-review-apr-product-quality-review-pqr)
  Streamline APR/PQR processes with QbD Group's expert support. Ensure compliance, timely reviews, and actionable insights for product quality and safety.
- [Regulatory Procedures](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-procedures)
  There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right path.
- [Cleaning Validation](https://qbdgroup.com/en/services/lab-services/cleaning-validation)
  Effective cleaning is essential to protect patient safety, and we can help you define a best practice approach in setting up plans and protocols for cleaning validation.
- [Regulatory Intelligence](https://qbdgroup.com/en/services/pharmacovigilance/regulatory-intelligence)
  Stay ahead of evolving regulations with QbD's regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed, data-driven insights.
- [Post-Market Clinical Follow-up](https://qbdgroup.com/en/services/clinical-solutions/pmcf/)
  Ensure EU MDR 2017/745 compliance with thorough pre-market and post-market processes. Validate device safety with robust data and proactive Post-Market Surveillance (PMS). Use PMCF activities for ongo
- [Process Validation](https://qbdgroup.com/en/services/qualification-validation/process-validation)
  Our experts are pleased to set up, improve and support the validation of your processes.
- [Elemental Impurities Reports](https://qbdgroup.com/en/services/toxicology/elemental-impurities-reports)
  Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports.
- [Data Integrity](https://qbdgroup.com/en/services/software-solutions-services/data-integrity)
  Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with 21 CFR Part 11 and EU Annex 11.
- [Pharmacovigilance QMS & PSMF](https://qbdgroup.com/en/services/pharmacovigilance/qms-psmf-services)
  Streamline your pharmacovigilance compliance with QbD's tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment.
- [Submissions](https://qbdgroup.com/en/services/regulatory-affairs/submissions)
  Your applications for marketing authorization must be accompanied correctly by the required documentation. Our Regulatory Affairs team will help you to get your documents right.
- [Organic Impurities Reports](https://qbdgroup.com/en/services/toxicology/organic-impurities-reports)
  We carry out toxicological evaluations of organic impurities according to ICH Q3A/B, assessing the toxicological risk and establishing a safety limit.
- [Medical Writing for In Vitro Diagnostics](https://qbdgroup.com/en/services/clinical-solutions/medical-writing-for-in-vitro-diagnostics)
  We offer writing, consulting, and documentation services for manufacturers of in vitro diagnostics and companion diagnostics
- [Residual Solvent Testing (GC)](https://qbdgroup.com/en/services/lab-services/residual-solvent-testing-gc)
  Reliable GMP-aligned residual solvent testing (GC) for APIs and finished products, ensuring compliance and patient safety.
- [QA Audits & Remediation](https://qbdgroup.com/en/services/quality-assurance/audits-and-remediation)
  Audits are viewed as a necessity. We strive to see any audit as an opportunity to gain more insights into the company itself and the quality management system, which ultimately leads to continuous imp
- [Cleaning Validation](https://qbdgroup.com/en/services/qualification-validation/cleaning-validation)
  QbD Group can support you in the validation and qualification of your cleanrooms, making sure your equipment is truly squeaky clean.
- [Clinical Strategy Support](https://qbdgroup.com/en/services/clinical-solutions/clinical-strategy-support)
  We can assist manufacturers by assembling a team of experts with diverse knowledge and backgrounds, such as physicians and clinical experts, to ensure all necessary perspectives are considered when bu
- [QMSR Compliance](https://qbdgroup.com/en/services/quality-assurance/qmsr-compliance)
  Align your quality system with the FDA's new rule (21 CFR Part 820 / ISO 13485:2016) and stay inspection-ready in the US market. Gap assessment, remediation, and inspection readiness for medical devic
- [Residual Solvents Reports](https://qbdgroup.com/en/services/toxicology/residual-solvents-reports)
  Ensure compliance and patient safety with QbD Group's residual solvent risk assessments, tailored to meet regulatory standards.
- [Microbiological Services](https://qbdgroup.com/en/services/lab-services/microbiological-analysis)
  We can support you with routine testing and validation of the microbiological purity of raw materials and finished medicinal products.
- [Software Implementations](https://qbdgroup.com/en/services/software-solutions-services/software-implementations)
  Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance.
- [Pharmacovigilance (PV) Audits](https://qbdgroup.com/en/services/pharmacovigilance/pv-audits-inspections-quality-system-management)
  Ensure compliance & inspection readiness with QbD's certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.
- [Analytical Method Validation](https://qbdgroup.com/en/services/qualification-validation/analytical-method-validation)
  QbD Qualification & Validation uses advanced tools and strict testing methods to ensure your analytical methods are accurate, precise, and reliable.
- [eCTD Publishing](https://qbdgroup.com/en/services/regulatory-affairs/ectd-publishing)
  The skills needed to confidently compile electronic submissions can take years of training. Let us be your guide for electronic submissions.
- [Toxicology](https://qbdgroup.com/en/services/toxicology)
  QbD Group offers a set of Toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX.
- [Elemental Impurities](https://qbdgroup.com/en/services/lab-services/elemental-impurities)
  ICH Q3 described expectations regarding the control of elemental impurities in medicinal products or their excipients. A control strategy should be implemented if the risk assessment shows that a sour
- [Clinical Pharmacovigilance Service](https://qbdgroup.com/en/services/clinical-solutions/clinical-pharmacovigilance-service)
  Ensuring comprehensive safety oversight is essential in clinical trials. Our expertise in pharmacovigilance could offer invaluable support.
- [Comprehensive Medical Information Services](https://qbdgroup.com/en/services/pharmacovigilance/comprehensive-medical-information-services)
  Enhance patient safety and product trust with QbD Group's expert medical information services, ensuring timely, accurate responses and compliance throughout your product lifecycle.
- [IT Infrastructure Qualification](https://qbdgroup.com/en/services/software-solutions-services/it-infrastructure-qualification)
  Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services.
- [Sterilization Validation](https://qbdgroup.com/en/services/qualification-validation/sterilization-validation)
  Ensure that your sterilization processes meet the most stringent standards, ensuring the integrity of your products and safeguarding public health.
- [Artwork & Labeling](https://qbdgroup.com/en/services/regulatory-affairs/artwork-labeling)
  Artwork and labeling play an important role in the marketing process of any pharmaceutical and are highly regulated.
- [REACH Registration & Compliance](https://qbdgroup.com/en/services/toxicology/reach-registration-compliance-support)
  Get expert support for REACH registration: substance ID, IUCLID dossiers, SDS, and CSR. Ensure compliance and streamline submissions with QbD Group.
- [Lifecycle Management](https://qbdgroup.com/en/services/regulatory-affairs/lifecycle-management)
  Our experts will accompany you throughout the whole Product Life Cycle Management process – from its conception, through design and manufacture, to service and disposal.
- [Monitoring Studies](https://qbdgroup.com/en/services/toxicology/monitoring-studies)
  Keep up to date with standards and ensure the safety of your product. With more than 10 years providing Toxicology Services, membership to AETOX and certified by EUROTOX.
- [QP Batch Release](https://qbdgroup.com/en/services/lab-services/qp-release-and-eu-import)
  Our Lab Services have authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC. Our own qualified persons (QPs) can certify the batch release testing.
- [Tech Transfer](https://qbdgroup.com/en/services/qualification-validation/tech-transfer)
  Tech Transfer is a vital process in translating innovation into real-world applications. Ensure a smooth transition and successful implementation with us at your side.
- [Data Management and Analysis](https://qbdgroup.com/en/services/clinical-solutions/data-management-and-analysis)
  Clinical data management leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. The clinical data manager oversees the development of data collection too
- [Paperless Validation](https://qbdgroup.com/en/services/software-solutions-services/paperless-validation)
  Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries.
- [Clinical Safety Management](https://qbdgroup.com/en/services/clinical-solutions/clinical-safety-management)
  Ensure safety and compliance in clinical trials with QbD Group's expert Clinical Safety Management solutions. Tailored to meet your trial needs.
- [Environmental Monitoring](https://qbdgroup.com/en/services/lab-services/environmental-monitoring)
  We have invested in state-of-the-art equipment to perform active air sampling, as well as compressed gas sampling for microbiological assessment or non-viable particle counting.
- [Information Officer](https://qbdgroup.com/en/services/regulatory-affairs/information-officer)
  A qualified Information Officer from QbD Group can coordinate and monitor pharmaceutical organizations' information management and marketing activities.
- [Process & Product Support](https://qbdgroup.com/en/services/qualification-validation/process-product-support)
  In today's competitive marketplace, optimization of processes and products can make a real difference. Working with QbD Group, you can trust that your processes and products will receive the support a
- [Biocompatibility & Biological Evaluation Solutions](https://qbdgroup.com/en/services/toxicology/biocompatibility-biological-evaluation)
  End-to-end biocompatibility and biological evaluation under ISO 10993, from feasibility and BEP to a submission-ready Biological Evaluation Report.
- [Software Validation, Central IT Systems](https://qbdgroup.com/en/services/software-solutions-services/software-validation)
  Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services.
- [Orphan Diseases](https://qbdgroup.com/en/services/regulatory-affairs/orphan-diseases)
  Rare diseases deserve just as much attention as more common diseases. We can support you in the development of medicines for patients suffering from rare diseases.
- [Clinical Evidence Support](https://qbdgroup.com/en/services/clinical-solutions/clinical-evidence-support)
  Our experts support your IVD or CDx with tailored clinical evidence strategies and documentation under IVDR.
- [R&D Projects](https://qbdgroup.com/en/services/lab-services/rd-projects)
  QbD Group's Lab Services is uniquely positioned to provide knowledge and customized solutions for the pharma industry.
- [Software Validation, Central IT Systems](https://qbdgroup.com/en/services/software-solutions-services/software-validation)
  Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to guarantee that your systems consisten
- [Clinical Quality Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-quality-services)
  Looking for support in setting up your clinical Quality Management System (QMS), revision of Standard Operating Procedures (SOPs) or an audit? QbD Clinical is your experienced partner for all your nee
- [Regulatory Intelligence](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-intelligence)
  Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.
- [Clinical Expert Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-expert-services)
  Are you looking for research professionals to support your clinical study under your own management or in an FSP (functional service provider) model? Our expert team of knowledgeable and well-trained 
- [RA Strategy for MD & IVD](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-strategy-md-ivd)
  Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks.
- [Experts in Medical Device Clinical Trials](https://qbdgroup.com/en/services/clinical-solutions/medical-device-clinical-trials)
  Expert support for medical device clinical trials, from strategy to post-market. Explore our services and real-world client success stories.
- [RA Design & Development](https://qbdgroup.com/en/services/regulatory-affairs/design-and-development)
  Embark on your journey by conceptualizing your IVD or MD. We will assist you in navigating the intricate landscape of design and development.
- [Technical Documentation](https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation)
  We can support the writing and compilation of IVDR/MDR-compliant technical documentation in line with your notified body's specific expectations.
- [Post-Market Performance Follow-up (PMPF)](https://qbdgroup.com/en/services/clinical-solutions/pmpf/)
  Ensure IVDR compliance with our PMPF services. We help confirm the performance and scientific validity of your IVDs through literature reviews, data analysis, and expert reporting.
- [Notified Body Submissions](https://qbdgroup.com/en/services/regulatory-affairs/notified-body-submissions)
  Navigating the submission process can be daunting, but you don't have to do it alone. Our experts can prepare and submit your application to the notified body.
- [Post-Market Surveillance](https://qbdgroup.com/en/services/regulatory-affairs/post-market-surveillance)
  Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD/Medical Device is on the market.
- [Authorised Representative Services](https://qbdgroup.com/en/services/regulatory-affairs/in-country-representative-services)
  If you want to sell your product in countries other than your own, it is important to consider the local regulations.
- [Person Responsible for Regulatory Compliance (PRRC)](https://qbdgroup.com/en/services/regulatory-affairs/person-responsible-for-regulatory-compliance)
  Are you looking for a person responsible for regulatory compliance (PRRC) for your IVDs or Medical Devices? We provide PRRC services to IVD/MD manufacturers with fewer than 50 employees.
- [Authorized Representative (EU-REP)](https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep)
  QbD Group, supported by the Qarad experts, is an independent partner that can act as your Authorized Representative (EC-REP).
- [Authorized Representative (CH-REP)](https://qbdgroup.com/en/services/regulatory-affairs/swiss-authorized-representative)
  Qarad Suisse S.A. – part of the QbD Group – is an independent partner that can act as your Swiss Authorized Representative (CH-REP).
- [UK Responsible Person (UKRP)](https://qbdgroup.com/en/services/regulatory-affairs/ukrp-uk-responsible-person)
  Qarad UK Ltd. – part of the QbD Group – is an independent partner that can act as your UK Responsible Person (UKRP).
- [Linguistic Review](https://qbdgroup.com/en/services/regulatory-affairs/linguistic-review)
  QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements.
- [Landing in Europe](https://qbdgroup.com/en/industries/pharma-biotech/landing-in-europe)
  Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance.
- [IVDR Compliance & CE Certification](https://qbdgroup.com/en/services/regulatory-affairs/ivdr-compliance-ce-certification)
  Strategic IVDR compliance for secure and sustainable EU market access. End-to-end support from regulatory roadmap to CE certification.
- [IVDD to IVDR Transition Support](https://qbdgroup.com/en/services/regulatory-affairs/ivdr-transition-support)
  Get expert support for your IVDD to IVDR transition. From gap assessment to submission, QbD ensures a smooth, compliant path to certification.
- [MDR Compliance – CE Certification for Medical Devices](https://qbdgroup.com/en/services/regulatory-affairs/mdr-compliance-ce-certification-for-medical-devices)
  Achieve EU MDR compliance with QbD Group's expert guidance, ensuring safety, quality, and market access for your medical devices.
- [MDD to MDR Transition Support](https://qbdgroup.com/en/services/regulatory-affairs/mdr-transition-support)
  Need support for your MDD to MDR transition? QbD Group guides you from gap assessment to CE submission.
- [Combination Products](https://qbdgroup.com/en/services/regulatory-affairs/combination-products)
  Navigate the complex regulatory pathways for combination products in the EU and US with QbD Group's expert guidance and tailored support.
- [Pharmacovigilance](https://qbdgroup.com/en/services/pharmacovigilance)
  QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety.
- [Legal Representative](https://qbdgroup.com/en/services/regulatory-affairs/legal-representative)
  If the sponsor of a performance study is not established in the European Union, we can ensure that a natural or legal person is established in the Union as its legal representative.
- [Liaison with Notified Bodies](https://qbdgroup.com/en/services/regulatory-affairs/liaison-with-notified-bodies)
  Strategic management of Notified Body interactions throughout the conformity assessment process for medical devices and IVDs.
- [Vigilance](https://qbdgroup.com/en/services/regulatory-affairs/materiovigilance)
  Incident monitoring and reporting for medical devices and IVDs
- [Coaching & Training](https://qbdgroup.com/en/services/regulatory-affairs/coaching-training)
  Tailored regulatory training programs to build practical MDR/IVDR competence within your medical device and IVD teams.
- [IFUcare](https://qbdgroup.com/en/services/software-solutions-services/ifucare)
  Discover how our eIFU service can help IVD and medical device manufacturers leave paper IFUs behind, saving costs, simplifying processes, and ensuring regulatory compliance. Developed by regulatory ex
- [Scilife™](https://qbdgroup.com/en/services/software-solutions-services/scilife)
  From document control and training to CAPAs and AI-driven KPIs, Scilife ensures full traceability, integration, and compliance. Its intuitive interface makes it easy to get started, and its powerful f

## Industries Served

- [Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech)
- [Medical Devices](https://qbdgroup.com/en/industries/medical-devices)
- [In Vitro Diagnostics (IVD)](https://qbdgroup.com/en/industries/in-vitro-diagnostics)
- [Companion Diagnostics (CDx)](https://qbdgroup.com/en/industries/companion-diagnostics)
- [Combination Products](https://qbdgroup.com/en/industries/combination-products)

## Blog Posts

- [Why Medical Inquiry Volumes Are Rising, and Why Your Current MI Model May Not Be Built for It](https://qbdgroup.com/en/blog/rising-medical-inquiry-volumes-mi-model) — 2026-09-09 · Pharmacovigilance · María Corrales
  Medical inquiry volumes are rising as products, patient expectations and regulatory requirements grow more complex. Is your Medical Information model ready?
- [The Contract Clause Your Combined CDx Study Site Agreement Is Probably Missing](https://qbdgroup.com/en/blog/cdx-site-agreement-ivdr-monitoring) — 2026-09-02 · Regulatory Affairs · Kirsten Van Garsse
  Discover why combined CDx site agreements need explicit IVDR monitoring and audit rights for test sites and sample collection sites.
- [Your CDx Submission Has Two Authors. Does It Read Like One?](https://qbdgroup.com/en/blog/cdx-submission-ctr-ivdr-alignment) — 2026-09-02 · Regulatory Affairs · Kirsten Van Garsse
  Learn why CDx clinical trial and IVDR performance study submissions must align while remaining independently complete for different regulatory reviewers.
- [Who Is the IVDR Sponsor of Your CDx Performance Study?](https://qbdgroup.com/en/blog/ivdr-sponsor-cdx-performance-study) — 2026-09-02 · Regulatory Affairs · Kirsten Van Garsse
  Who holds IVDR sponsorship in a CDx performance study? Learn why sponsor roles, delegation and governance must be defined early in combined studies.
- [How AI Is Reshaping Medical Information: What Pharma Companies Need to Prepare For](https://qbdgroup.com/en/blog/ai-medical-information-pharma) — 2026-07-22 · Pharmacovigilance · María Corrales
  Discover how AI is transforming Medical Information, why regulators are increasing oversight, and how pharma companies can prepare for a future-ready MI operating model.
- [Designed for Approval, Judged by Adoption: Where Oncology IVD Clinical Studies Slip](https://qbdgroup.com/en/blog/oncology-ivd-clinical-study-design-mistakes) — 2026-07-10 · Clinical · Annelies Rotthier
  Discover why oncology IVD clinical performance studies often fail beyond regulatory approval, and how better study design supports reimbursement and clinical adoption.
- [When AI Says "Expected": Automation Bias and the SUSAR That Slips Through](https://qbdgroup.com/en/blog/automation-bias-ai-susar-reporting-risk) — 2026-07-08 · Pharmacovigilance · Anam Ahmad
  Discover how automation bias in AI-supported SAE and SUSAR workflows can lead to missed expedited reporting obligations and increased pharmacovigilance risk.
- [Human in the Loop, Accountable on the Record: Governing AI in Clinical Trial Safety](https://qbdgroup.com/en/blog/human-in-the-loop-ai-clinical-trial-safety) — 2026-07-08 · Pharmacovigilance · Anam Ahmad
  Learn how sponsors and CROs can govern AI in SAE and SUSAR management through human oversight, explainability, validation, and regulatory compliance.
- [Where Pharmacovigilance Meets Materiovigilance: AI Safety in Device and Combination Product Trials](https://qbdgroup.com/en/blog/ai-safety-device-combination-product-trials) — 2026-07-08 · Pharmacovigilance · Anam Ahmad
  Discover how AI supports safety surveillance in medical device and combination product trials, and what sponsors must consider for governance and compliance.
- [Designed for a Moving Target: Building Oncology IVD Programmes That Survive Scientific Change](https://qbdgroup.com/en/blog/oncology-ivd-scientific-change-strategy) — 2026-07-08 · Clinical · Annelies Rotthier
  For founders, CSOs, and regulatory leads at oncology IVD companies operating in fast-evolving biomarker landscapes.
- [How to Manage Regulatory Lifecycle Complexity During International Expansion](https://qbdgroup.com/en/blog/regulatory-lifecycle-management-international-expansion) — 2026-07-01 · Regulatory Affairs · Joanna Rapacz & Almudena del Castillo
  Discover how pharmaceutical companies can manage Regulatory Affairs and Pharmacovigilance across multiple markets through scalable Lifecycle Management and integrated governance.
- [Defining the Intended Purpose: The Strategic Foundation of Oncology IVD Development](https://qbdgroup.com/en/blog/intended-purpose-oncology-ivd-development) — 2026-07-01 · Clinical · Annelies Rotthier
  Learn why the intended purpose statement is the most important strategic decision in oncology IVD development and how it shapes regulatory approval, clinical evidence, reimbursement, and adoption.
- [Annex 11 V4: What Is Changing, and What Your Company Might Have Skipped](https://qbdgroup.com/en/blog/annex-11-v4-changes-what-companies-skipped) — 2026-06-30 · Software Solutions & Services · Jan Appelmans
  EU GMP Annex 11 V4 is expected summer 2026. See what's changing from the 2011 version and which good practices your company may have skipped.
- [GAMP 5 vs Computer Software Assurance (CSA): A Practical Comparison Guide](https://qbdgroup.com/en/blog/gamp-5-vs-csa-comparison-guide) — 2026-06-29 · Qualification & Validation · Jan Appelmans
  A practical guide comparing the traditional GAMP 5 validation framework with the risk-based Computer Software Assurance (CSA) approach, including when to use each and how to implement a hybrid strategy.
- [CMC & Quality Readiness: Avoiding the Gaps That Delay First-in-Human Trials](https://qbdgroup.com/en/blog/cmc-quality-readiness-first-in-human-trials) — 2026-06-24 · Regulatory Affairs · Angeles Escartí-Nebot
  Discover the most common CMC and quality gaps that delay First-in-Human trials and learn how to align manufacturing, regulatory, and clinical readiness.
- [Extractables & Leachables and ICH Q3E: What Has Changed and What Hasn't](https://qbdgroup.com/en/blog/extractables-leachables-ich-q3e-what-has-changed) — 2026-06-24 · Javier López
  Discover what the draft ICH Q3E guideline means for Extractables & Leachables programmes, from lifecycle management and documentation to risk-based decision-making.
- [The QMSR Deadline Has Passed, but Companies Are Still Searching for Guidance](https://qbdgroup.com/en/blog/qmsr-deadline-passed-still-searching-guidance) — 2026-06-19 · Quality Assurance · Tiago de Matos Lourenço
  The FDA QMSR is now in force. Learn where medical device and IVD manufacturers still struggle with QMSR compliance and what to prioritise next.
- [Integrating New Products and Acquisitions Without Losing Control of Lifecycle Management](https://qbdgroup.com/en/blog/integrating-products-acquisitions-lifecycle-management) — 2026-06-18 · Regulatory Affairs · Joanna Rapacz & Almudena del Castillo
  Acquiring or licensing new pharma products introduces complexity across RA and PV. Learn how a structured Lifecycle Management framework helps maintain compliance and control during integration.
- [Annex 1 Implementation: Key Recommendations for Effective Contamination Control](https://qbdgroup.com/en/blog/annex-1-implementation-contamination-control) — 2026-06-12 · Qualification & Validation · Jo Doucet
  EU GMP Annex 1 compliance goes beyond documentation. Discover the four critical areas manufacturers must address to build effective contamination control and maintain inspection readiness.
- [ATMPs: translating the expertise into a GMP process](https://qbdgroup.com/en/blog/atmps-translating-the-expertise-into-a-gmp-process) — 2026-06-11 · Pharma & Biotech · Roberta Sgammato
  ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.
- [The 5 Most Common Mistakes in Thermal Qualification Projects (and How to Avoid Them)](https://qbdgroup.com/en/blog/common-mistakes-thermal-qualification-projects) — 2026-06-10 · Qualification & Validation · Rodrigo Mondelo Ripoll
  Discover the most common mistakes in thermal qualification projects and learn how a risk-based, lifecycle approach can improve GMP compliance, efficiency, and project success.
- [How to Sustain Portfolio Growth Without Increasing Lifecycle Complexity](https://qbdgroup.com/en/blog/sustain-portfolio-growth-lifecycle-management) — 2026-06-08 · Regulatory Affairs · Joanna Rapacz & Almudena del Castillo
  More products, more obligations. Discover how a scalable Lifecycle Management model keeps your RA and PV operations in control as your portfolio grows.
- [How to plan and execute a thermal qualification project in pharma: a step-by-step guide](https://qbdgroup.com/en/blog/plan-execute-thermal-qualification-project-pharma) — 2026-06-04 · Qualification & Validation · Rodrigo Mondelo Ripoll
  Learn the key phases of a thermal qualification project, from scope definition and protocol execution to deviation management and final reporting.
- [Thermal system qualification in pharmaceutical facilities: regulatory framework and key success factors](https://qbdgroup.com/en/blog/thermal-system-qualification-pharmaceutical-facilities) — 2026-06-04 · Qualification & Validation · Rodrigo Mondelo Ripoll
  Discover the key GMP requirements, IQ/OQ/PQ phases, and common pitfalls involved in thermal system qualification in pharmaceutical facilities.
- [What to Look for When Selecting a CRO for IVD Performance Studies](https://qbdgroup.com/en/blog/selecting-cro-ivd-performance-studies) — 2026-05-20 · Clinical · Annelies Rotthier & Kirsten Van Garsse
  Not every CRO is equipped for IVD performance studies. Learn the nine capabilities that matter most for compliant, defensible evidence generation.
- [Three Sponsorship Models for Combined IVD-Drug Studies: How to Choose the Right One for Your Program](https://qbdgroup.com/en/blog/three-sponsorship-models-combined-ivd-drug-studies) — 2026-05-20 · Clinical · Annelies Rotthier & Kirsten Van Garsse
  Explore the three main sponsorship models for combined IVD-drug studies and learn how governance structures impact compliance, timelines, and data ownership.
- [Delegation vs. Transfer of Sponsor Responsibilities: The Line Every IVD Performance Study Sponsor Needs to Draw](https://qbdgroup.com/en/blog/delegation-vs-transfer-sponsor-responsibilities-ivd) — 2026-05-20 · Clinical · Annelies Rotthier & Kirsten Van Garsse
  Understand the difference between delegating operational tasks and transferring Sponsor responsibilities in IVD performance studies under IVDR and FDA frameworks.
- [Who Is the Sponsor of Your IVD Performance Study and Why It Matters More Than You Think](https://qbdgroup.com/en/blog/sponsor-ivd-performance-study-responsibilities) — 2026-05-20 · Clinical · Annelies Rotthier & Kirsten Van Garsse
  Learn who carries Sponsor responsibility in IVD performance studies and why this role shapes compliance, data ownership, and regulatory success.
- [Why Most AI Pilots Fail in Regulated Environments and How to Fix It](https://qbdgroup.com/en/blog/why-most-ai-pilots-fail-regulated-environments) — 2026-05-17 · Software Solutions & Services · Jonathan Boel
  Discover why AI pilots in pharma often fail before production and how governance, workflows, and data foundations determine success.
- [How MedTech's AI Playbook Can Accelerate Compliant AI Adoption in Pharma](https://qbdgroup.com/en/blog/medtech-ai-playbook-compliant-ai-adoption-pharma) — 2026-05-13 · Software Solutions & Services · Pieter Smits & Jonathan Boel
  Discover how MedTech's validated AI approach can help pharma accelerate compliant AI adoption across R&D, clinical trials, and GMP operations.
- [AI in Life Sciences: From Hype to Compliant Reality](https://qbdgroup.com/en/blog/ai-life-sciences-compliant-reality) — 2026-05-13 · Software Solutions & Services · Jonathan Boel
  Discover why governance, validation, and trust, not model performance, are the real challenges for AI adoption in life sciences.
- [Why AI Is Too Generic for Regulatory Conversations in Life Sciences](https://qbdgroup.com/en/blog/why-ai-too-generic-for-regulatory-conversations) — 2026-05-13 · Software Solutions & Services · Pieter Smits
  Discover why AI governance in life sciences depends on intended use, risk context, and control frameworks rather than the AI label itself.
- [Structural Heart and Coronary Trials in Europe: What Can Go Wrong](https://qbdgroup.com/en/blog/structural-heart-coronary-trial-pitfalls-europe) — 2026-05-13 · Clinical · Ayelen Gaitan & Sophie Achten
  Discover the most common operational and regulatory pitfalls in structural heart and coronary trials across Europe, and how to mitigate them early.
- [Running Your First Structural Heart Trial in Europe: What to Expect Before You Start](https://qbdgroup.com/en/blog/first-structural-heart-trial-europe) — 2026-05-13 · Clinical · Ayelen Gaitan & Sophie Achten
  Discover what non-EU sponsors should expect when launching a first structural heart or coronary device trial in Europe under the MDR framework.
- [Bringing ERA into Practice: Key Challenges in Pharma](https://qbdgroup.com/en/blog/environmental-risk-assessment-pharma-challenges) — 2026-05-06 · Toxicology · Natalia Herrera
  Discover the practical challenges of Environmental Risk Assessments (ERAs) in pharma, from toxicology input to data consistency and lifecycle management.
- [Governance in Combined Studies: Getting Roles Right Before the Clock Starts](https://qbdgroup.com/en/blog/governance-combined-drug-diagnostic-studies) — 2026-05-06 · Regulatory Affairs · Kirsten Van Garsse
  Discover why governance and role clarity are critical in combined drug-diagnostic studies under the CTR and IVDR.
- [Why Pharma and IVD Partners Must Collaborate Earlier Than You Think](https://qbdgroup.com/en/blog/pharma-ivd-partner-collaboration-cdx-development) — 2026-05-06 · Regulatory Affairs · Kirsten Van Garsse
  Discover why early collaboration between pharma sponsors and IVD partners is critical for successful companion diagnostic development under the IVDR.
- [The Harmonisation Gap: Managing EU Performance Study Submissions](https://qbdgroup.com/en/blog/ivdr-performance-study-submissions-europe) — 2026-05-06 · Kirsten Van Garsse
  Discover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy.
- [No Shortcuts: Why In-House Devices Under Article 5(5) Are Not the Easy Route](https://qbdgroup.com/en/blog/article-5-5-in-house-devices-ivdr) — 2026-05-06 · Regulatory Affairs · Kirsten Van Garsse
  Thinking Article 5(5) is the easy route under the IVDR? Discover the hidden obligations and risks of in-house devices.
- [When Does Your Diagnostic Become an IVD in a Clinical Trial?](https://qbdgroup.com/en/blog/when-does-diagnostic-become-ivd-clinical-trial) — 2026-05-06 · Regulatory Affairs · Kirsten Van Garsse
  Discover when an assay used in a clinical trial falls under the IVDR and what this means for timelines, compliance, and study strategy.
- [A 7-Phase Framework for AI/ML Compliance in Life Sciences](https://qbdgroup.com/en/blog/ai-compliance-framework-life-sciences) — 2026-04-29 · Software & Digital Health · Jonathan Boel
  Discover a 7-phase AI/ML compliance framework for life sciences, covering data governance, validation, and post-launch monitoring under GxP.
- [What Pharma Can Learn from MedTech's AI Validation Playbook](https://qbdgroup.com/en/blog/ai-validation-pharma-medtech-lessons) — 2026-04-29 · Software & Digital Health · Pieter Smits
  Pharma is still figuring out AI validation. MedTech already solved it. Learn what to copy from MedTech's proven playbook to ensure GxP compliance and real-world impact.
- [The Hidden Operational Hurdles of EU Market Entry](https://qbdgroup.com/en/blog/eu-mdr-operational-requirements-market-entry) — 2026-04-29 · Regulatory Affairs · Anne-Sophie Grell & Petra De Geest
  CE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.
- [Why Clinical Strategy Is the Real Bottleneck for EU Market Access](https://qbdgroup.com/en/blog/clinical-strategy-eu-mdr-market-access) — 2026-04-29 · Regulatory Affairs · Anne-Sophie Grell & Petra De Geest
  Discover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.
- [Clinical Evidence Under EU MDR: What Non-EU Manufacturers Get Wrong](https://qbdgroup.com/en/blog/eu-mdr-clinical-evidence-medical-devices) — 2026-04-29 · Regulatory Affairs · Anne-Sophie Grell & Petra De Geest
  Discover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.
- [The EU Notified Body Process: What Every Non-EU Manufacturer Should Know](https://qbdgroup.com/en/blog/eu-notified-body-process-medical-devices) — 2026-04-29 · Regulatory Affairs · Anne-Sophie Grell & Petra De Geest
  Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.
- [Why FDA or NMPA Approval Does Not Mean You're Ready for Europe](https://qbdgroup.com/en/blog/fda-nmpa-approval-not-eu-mdr-readiness) — 2026-04-29 · Regulatory Affairs · Anne-Sophie Grell & Petra De Geest
  FDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.
- [Structural Heart and Coronary Trial Feasibility in Europe: What It Takes](https://qbdgroup.com/en/blog/structural-heart-coronary-trial-feasibility-europe) — 2026-04-29 · Clinical · Ayelen Gaitan & Sophie Achten
  What does it really take to run a successful cardiac trial in Europe? Discover key feasibility factors, from site selection to regulatory timelines and patient access.
- [Cardiac Device Success in Europe: Structural Heart and Coronary Trials](https://qbdgroup.com/en/blog/cardiac-device-trials-europe-mdr-strategy) — 2026-04-29 · Clinical · Ayelen Gaitan & Sophie Achten
  Discover why Europe is ideal for cardiac device trials. Learn how MDR strategy and CRO support accelerate structural heart and coronary studies.
- [EU and UK Regulatory Submissions: Platforms, Authority Interactions and Timeline Control](https://qbdgroup.com/en/blog/eu-uk-regulatory-submissions-fda-dossier) — 2026-04-14 · Regulatory Affairs · Angeles Escartí Nebot
  Entering Europe after FDA approval? Learn how to manage EU and UK regulatory submissions, authority interactions, and submission timelines efficiently.
- [First-in-Human Operational Readiness for Emerging Biotechs: The Minimum Framework You Need](https://qbdgroup.com/en/blog/first-in-human-operational-readiness-biotechs) — 2026-04-13 · Regulatory Affairs · Sacha Lynch
  Prepare for First-in-Human trials with the right operational framework. Align safety, governance, and clinical execution to meet regulatory expectations.
- [Operational Readiness for Europe: PV, QA and MAH Requirements Biotechs Cannot Ignore](https://qbdgroup.com/en/blog/eu-operational-readiness-pv-qa-mah-requirements) — 2026-04-12 · Regulatory Affairs · Angeles Escartí-Nebot
  Entering the EU market requires more than approval. Discover the pharmacovigilance, quality, and MAH requirements biotechs must prepare before European launch.
- [Utilities and Pharmaceutical Water Systems: A Hidden Compliance Risk Under Annex 1](https://qbdgroup.com/en/blog/annex-1-utilities-pharmaceutical-water-systems) — 2026-04-01 · Qualification & Validation · Jo Doucet
  Utilities such as pharmaceutical water systems and gases are often overlooked in Annex 1 remediation. Discover common compliance gaps and how to mitigate them.
- [Extractables and Leachables (E&L): Reviewing the Current Regulatory Landscape](https://qbdgroup.com/en/blog/extractables-leachables-regulatory-requirements-ich-q3e) — 2026-04-01 · María José Villarroel and Javier López
  Extractables and leachables requirements are evolving with draft ICH Q3E. Learn how companies can prepare for future E&L regulatory expectations.
- [Scaling Pharmacovigilance Across Europe: Managing Local Requirements Without Losing Control](https://qbdgroup.com/en/blog/scaling-pharmacovigilance-europe) — 2026-03-27 · Pharmacovigilance · Almudena del Castillo
  Expanding across Europe introduces complex pharmacovigilance requirements. Learn how EU PV systems can scale while integrating national roles and regulatory obligations.
- [AI in Pharmacovigilance: Efficiency Tool or Strategic Game-Changer?](https://qbdgroup.com/en/blog/ai-pharmacovigilance-strategy) — 2026-03-25 · Pharmacovigilance · Almudena del Castillo
  AI is transforming pharmacovigilance processes from case processing and literature monitoring to signal detection. Discover how AI and NLP can enhance efficiency, compliance, and regulatory intelligence.
- [From R&D to Market: Why the Product Lifecycle Is the Strategic Framework for MedTech](https://qbdgroup.com/en/blog/medtech-product-lifecycle-strategy) — 2026-03-25 · Regulatory Affairs · Anne-Sophie Grell, Regulatory Affairs Manager at QbD Group
  Successful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.
- [SaMD Under EU MDR: What Software Developers Need to Know](https://qbdgroup.com/en/blog/samd-regulatory-requirements-eu-mdr) — 2026-03-24 · Regulatory Affairs · Anne-Sophie Grell
  Developing Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.
- [IP Strategy for MedTech Startups: What Early-Stage Companies Often Miss](https://qbdgroup.com/en/blog/ip-strategy-medtech-startups) — 2026-03-23 · Regulatory Affairs · Anne-Sophie Grell
  IP strategy should start early in MedTech development. Discover how patent strategy, regulatory classification, and product development influence IP protection for emerging MedTech companies.
- [EU MDR Compliance for MedTech Startups: What It Really Takes](https://qbdgroup.com/en/blog/mdr-compliance-medtech-startups) — 2026-03-22 · Regulatory Affairs · Anne-Sophie Grell
  EU MDR compliance can be challenging for emerging MedTech companies. Learn what MDR actually requires, from qualification and QMS to technical documentation and post-market obligations.
- [3 Things MedTech Startups Get Wrong About IP & Regulatory Strategy](https://qbdgroup.com/en/blog/medtech-ip-regulatory-strategy-mistakes) — 2026-03-21 · Regulatory Affairs · Anne-Sophie Grell
  Many MedTech startups treat IP and regulatory strategy as separate disciplines. Discover the three most common mistakes and how aligning both early strengthens market access and product value.
- [Scientific Advice for Startups: Turning the Right Questions into Regulatory Clarity](https://qbdgroup.com/en/blog/scientific-advice-biotech-startups-ema-strategy) — 2026-03-04 · Regulatory Affairs · Angeles Escartí-Nebot
  Scientific Advice is one of the few moments in early development where a biotech can test its assumptions with regulators. Learn how to structure questions, integrate CMC and clinical strategy, and leverage EMA SME support for maximum impac
- [People as a Critical Risk Factor in Annex 1: Personnel Gowning, Training and Aseptic Behaviour](https://qbdgroup.com/en/blog/annex-1-personnel-contamination-risk) — 2026-03-04 · Qualification & Validation · Stan Van Kerkhoven
  Annex 1 places strong emphasis on personnel behaviour in sterile manufacturing. Learn how gowning, training, and aseptic discipline influence contamination control.
- [Pre-Submission Optimization for EU/UK: How US Biotechs Can Adapt FDA Packages Efficiently](https://qbdgroup.com/en/blog/fda-to-eu-uk-submission-strategy) — 2026-03-04 · Regulatory Affairs · Angeles Escartí-Nebot
  For US biotechs expanding into the EU and UK, successful submission conversion requires early planning, clear ownership, and a structured approach. Learn how to build a reuse map, manage parallel conversion tracks, and avoid late-stage rewo
- [Annex 15 Revision: What API Manufacturers Must Prepare for Now](https://qbdgroup.com/en/blog/annex-15-revision-api-validation-preparation) — 2026-02-25 · Qualification & Validation · Jo Doucet
  The Annex 15 revision will make qualification and validation mandatory for API manufacturers. Learn how to prepare lifecycle validation and inspection readiness.
- [Planning EU Expansion: What US Biotechs Must Get Right From Day One](https://qbdgroup.com/en/blog/eu-expansion-strategy-us-biotechs) — 2026-02-18 · Regulatory Affairs · Angeles Escartí-Nebot, Global Head Regulatory Affairs at QbD Group
  Planning EU and UK expansion as a US biotech? Learn which regulatory, clinical and operational decisions matter from day one.
- [Residual Solvent Testing in Pharmaceuticals: From Process to Patient](https://qbdgroup.com/en/blog/residual-solvent-testing-pharmaceuticals) — 2026-02-18 · Lab Services · Yves Peeraer, Division Head Lab Services at QbD Group
  Residual solvent testing is essential to patient safety and regulatory compliance. Learn how GC-FID and GC-MS support ICH Q3C compliance in pharmaceutical manufacturing.
- [Scaling PV Governance in Europe: Maintaining Oversight as Organizations Grow](https://qbdgroup.com/en/blog/scaling-pv-governance-europe-eu-qppv-oversight) — 2026-02-13 · Pharmacovigilance · Almudena del Castillo, Country Manager Spain & Head of Global Vigilance Division at QbD Group
  As European SMEs and biotechs expand, PV governance must scale to maintain EU-QPPV oversight and inspection readiness. Learn how to build a scalable pharmacovigilance system.
- [Cleanrooms, Isolators and RABS: Meeting Annex 1 Expectations for Modern Aseptic Manufacturing](https://qbdgroup.com/en/blog/annex-1-cleanrooms-isolators-rabs-aseptic-manufacturing) — 2026-02-13 · Qualification & Validation · Jo Doucet, Division Head Qualification/Validation at QbD Group
  Learn how Annex 1 expectations for cleanrooms, isolators and RABS shape modern aseptic manufacturing. Practical guidance on barrier strategy, airflow visualization and contamination control.
- [Deciding Early on an Orphan Strategy: A Strategic Choice, Not a Checkbox](https://qbdgroup.com/en/blog/early-orphan-strategy-eu-us-uk) — 2026-02-13 · Pharma & Biotech · Angeles Escartí-Nebot, Global Head Regulatory Affairs at QbD Group
  Orphan strategy decisions go beyond incentives. Learn how regulatory definitions, evidence requirements, timing, and exclusivity across the EU, US, and UK shape early biotech development strategy.
- [Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights](https://qbdgroup.com/en/blog/nitrosamine-impurities-in-medicinal-products-risks-and-regulatory-insights) — 2026-02-09 · Pharma & Biotech · Pablo Palomar
  Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.
- [Strategic Choices That Define a Biotech's Path to the Clinic: First-in-Human Is Earned Long Before It Begins](https://qbdgroup.com/en/blog/early-biotech-strategy-first-in-human-eu-uk) — 2026-02-04 · Regulatory Affairs · Angeles Escartí-Nebot
  Early strategic choices define whether a biotech reaches first-in-human smoothly. Learn how EU/UK regulatory, CMC and quality decisions shape success.
- [Contamination Control Strategy (CCS) and Aseptic Process Design: Making Annex 1 Work in Real Life](https://qbdgroup.com/en/blog/contamination-control-strategy-aseptic-process-design-annex-1) — 2026-01-28 · Qualification & Validation · Jo Doucet & Stan Van Kerkhoven, Stan Van Kerkhoven, Jo Doucet
  How a practical Contamination Control Strategy and aseptic process design help manufacturers meet EU GMP Annex 1 expectations in real operations.
- [Designing Meaningful Dissolution Tests: Practical Foundations and Pharmaceutical Applications](https://qbdgroup.com/en/blog/designing-meaningful-dissolution-tests-pharma) — 2025-12-17 · Lab Services · Yves Peeraer
  Learn how to design meaningful dissolution tests that support formulation development, quality control, and regulatory compliance in pharma.
- [How to Integrate Outsourced QA into Your QMS (Without Losing Oversight)](https://qbdgroup.com/en/blog/integrate-outsourced-qa-into-qms) — 2025-12-12 · Quality Assurance · Martine Suckers
  Explore how outsourced QA can strengthen your QMS through structured governance and seamless integration.
- [EU MDR Bottleneck Ahead: Why 2026 Will Be a Defining Year for Medical Device Manufacturers](https://qbdgroup.com/en/blog/eu-mdr-bottleneck-2026-medical-device-manufacturers) — 2025-12-12 · Regulatory Affairs · Sarah Schouteden
  EU MDR deadlines converge in 2026. Notified Body bottlenecks and EUDAMED go-live put medical device manufacturers under pressure.
- [The Evolution and Importance of Dissolution Testing in Pharma](https://qbdgroup.com/en/blog/evolution-of-dissolution-testing) — 2025-12-03 · Lab Services · Yves Peeraer
  Learn how dissolution testing evolved and what today’s advanced methods mean for faster development, stronger QC, and smoother regulatory approval.
- [Validating Single-Use Systems in Biopharma: Key Requirements and Emerging Expectations](https://qbdgroup.com/en/blog/single-use-systems-validation-best-practices) — 2025-12-03 · Qualification & Validation · Jo Doucet, Division Head Qualification/Validation at QbD Group
  Learn the key requirements for validating Single-Use Systems, with guidance on supplier control, compliance, and Extractables & Leachables risk management.
- [European Pharmacopoeia Chapter 2.4.35 on Extractable Elements in Plastics for Pharmaceutical Use](https://qbdgroup.com/en/blog/url-european-pharmacopoeia-2-4-35-extractable-elements) — 2025-11-19 · Lab Services · Yves Peeraer, Division Head Lab Services at QbD Group
  Ph. Eur. Chapter 2.4.35 defines a harmonized approach to assess extractable elements in plastic pharmaceutical materials, strengthening risk-based control of elemental impurities.
- [Validating Your QMS: What Pharma Professionals Need to Know](https://qbdgroup.com/en/blog/validate-qms-pharma-guide) — 2025-11-12 · Software Solutions & Services · Maria Fossati
  Learn why QMS validation matters in pharma, what regulators expect, and how to apply Annex 11, 21 CFR Part 11, and GAMP 5 best practices to stay compliant.
- [The UK Responsible Person (UKRP): Your Official Representative and First Step into the UK Market](https://qbdgroup.com/en/blog/uk-responsible-person-ukrp-medical-devices-ivds) — 2025-11-12 · Regulatory Affairs · Kirsten Van Garsse
  Learn the role of the UK Responsible Person (UKRP) for medical devices and IVDs, and how they ensure compliance with MHRA requirements in Great Britain.
- [The Critical Role of the CH-REP in Swiss Market Access](https://qbdgroup.com/en/blog/ch-rep-swiss-market-access-medical-devices-ivds) — 2025-11-12 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  Learn how the Swiss Authorised Representative (CH-REP) ensures compliance with MedDO and IvDO requirements for medical devices and IVDs in Switzerland.
- [How to Prepare a Submission-Ready Environmental Risk Assessment (ERA)](https://qbdgroup.com/en/blog/environmental-risk-assessment-ema-guideline) — 2025-11-07 · Quality Assurance · Mae Ann Belandres
  Learn how to prepare a compliant, submission-ready Environmental Risk Assessment (ERA) under the 2024 EMA guideline, with tips for data, logic, and reporting.
- [Your Gateway to the EU Market: The Crucial Role of the Authorised Representative](https://qbdgroup.com/en/blog/eu-authorised-representative-mdr-ivdr) — 2025-11-07 · Regulatory Affairs · Kirsten Van Garsse
  Learn why an EU Authorised Representative is essential for MDR and IVDR compliance — and how QbD RepS BV helps non-EU manufacturers enter the EU market with confidence.
- [Inside the EudraLex Annex 22: What’s New for AI in Pharma Manufacturing and Why These Revisions Matter](https://qbdgroup.com/en/blog/eudralex-annex-22-whats-new-for-ai-in-pharma) — 2025-10-31 · Software Solutions & Services · Ward Neefs, Life Science Consultant at QbD Group
  Learn what the new EudraLex Annex 22 means for AI regulation in pharma and how it could impact your daily operations and compliance efforts.
- [Analytical Method Validation: From One-Time Event to Lifecycle Approach](https://qbdgroup.com/en/blog/analytical-method-validation-lifecycle-approach) — 2025-10-31 · Qualification & Validation · Bianca van de Swaluw, Senior Life Science Consultant at QbD Group
  ICH Q2(R2) and Q14 redefine method validation as a continuous lifecycle. Learn how to keep analytical methods fit for purpose and inspection-ready.
- [Enabling Pharmacovigilance Scale: The Role of Data, Systems, and People](https://qbdgroup.com/en/blog/enabling-pharmacovigilance-scale-data-systems-and-people) — 2025-10-28 · Pharmacovigilance · Almudena del Castillo
  Learn how to scale pharmacovigilance across Europe efficiently by managing data, systems, and people while maintaining compliance with Good Pharmacovigilance Practices (GVP).
- [Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment](https://qbdgroup.com/en/blog/environmental-risk-assessments-era-in-pharma-balancing-health-amp-environment) — 2025-10-27 · Pharma & Biotech · María José Villarroel
  Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological preservation.
- [Boosting Compliance and Efficiency: How External Expertise Strengthens APR/PQR Compliance](https://qbdgroup.com/en/blog/apr-pqr-external-expertise-compliance) — 2025-10-24 · Quality Assurance · Martine Suckers
  Tight deadlines, mounting data, and inspection pressure. Discover how external expertise can turn APR/PQR from a yearly compliance burden into a streamlined, insight-driven advantage for your QA team.
- [IVD Use in EU Clinical Trials: Key Considerations Under the IVDR](https://qbdgroup.com/en/blog/ivd-use-in-eu-clinical-trials) — 2025-10-10 · Regulatory Affairs · Kirsten Van Garsse & Annelies Rotthier
  Unsure whether your IVD requires a legal representative under the IVDR? Learn the difference between in-house use, performance studies, and companion diagnostics.
- [Bridging the Regulatory Gap: Integrating IVDs into Global Clinical Trials](https://qbdgroup.com/en/blog/ivd-clinical-trials-integration) — 2025-10-10 · Regulatory Affairs · Kirsten Van Garsse & Annelies Rotthier
  Learn how to integrate IVDs into global clinical trials while meeting IVDR and CTR requirements. Practical tips, real-world cases, and QbD expertise.
- [Scale Smart: Choosing the Right Pharmacovigilance Operating Model for EU Growth](https://qbdgroup.com/en/blog/pharmacovigilance-operating-model-eu-growth) — 2025-10-08 · Pharmacovigilance · Almudena del Castillo
  How to choose the right pharmacovigilance operating model (centralized, hybrid, decentralized) to scale smart across Europe while staying compliant.
- [The Eyes of High-Performance Liquid Chromatography (HPLC): Strategic Use of Detectors in Drug Development and Quality Control](https://qbdgroup.com/en/blog/hplc-detectors-drug-development-quality-control) — 2025-10-08 · Lab Services · Yves Peeraer
  Explore UV-Vis, PDA, Fluorescence, RID, MS, and Conductivity detectors in HPLC. Learn strengths, limits, and applications in pharma R&D and QC.
- [Toxicological Assessment of Extractables and Leachables (E&L)](https://qbdgroup.com/en/blog/toxicological-assessment-of-extractables-and-leachables) — 2025-10-08 · Pharma & Biotech · Ana San Martín Cuende, Senior Toxicology Officer
  Learn about Extractables and Leachables in pharmaceuticals, including regulatory guidelines, analytical techniques, and safety assessments.
- [Local Pharmacovigilance Matters: Where Global Strategy Meets On-the-Ground Reality](https://qbdgroup.com/en/blog/local-pharmacovigilance) — 2025-10-06 · Pharmacovigilance · Almudena del Castillo, Country Manager Spain & Head of Global Vigilance Division at QbD Group
  Global PV success requires more than compliance. Discover how hybrid pharmacovigilance models help pharma companies meet local regulatory demands and build patient trust.
- [Environmental Risk Assessment (ERA) in Drug Products: Understanding the EMA Guideline](https://qbdgroup.com/en/blog/environmental-risk-assessment-update) — 2025-10-06 · Regulatory Affairs · Mae Ann Belandres, Senior Consultant Toxicology
  Learn how the EMA guideline defines Environmental Risk Assessment (ERA) for drug products, including its structure, key phases, and implications for pharmaceutical development.
- [FDA Expands Unannounced Foreign Inspections: How to Stay Inspection Ready](https://qbdgroup.com/en/blog/stay-inspection-ready-fda-foreign-inspections) — 2025-10-01 · Qualification & Validation · Dominiek Rossillion, Division Head Quality Assurance at QbD Group
  FDA is expanding unannounced inspections at foreign sites. Learn how manufacturers can stay inspection ready through resilient systems, validated processes, and confident people.
- [MDR & Cybersecurity: What Your Technical File Needs to Prove](https://qbdgroup.com/en/blog/mdr-cybersecurity-technical-file) — 2025-09-25 · Software Solutions & Services · Pieter Smits, Project Manager at QbD Group
  Cybersecurity is a key MDR requirement. Discover what your technical file must include to meet EU cybersecurity expectations for medical devices.
- [Commissioning & Qualification of Temperature-Controlled Storage Equipment in Pharma](https://qbdgroup.com/en/blog/temperature-controlled-storage-pharma) — 2025-09-24 · Qualification & Validation · Rik Seymus
  Learn how to commission and qualify pharma storage equipment. Ensure compliance, product safety, and reliable temperature control.
- [Eudralex Annex 11 Revision: What Pharma Companies Need to Know Before 2026](https://qbdgroup.com/en/blog/annex-11-revision-digital-compliance) — 2025-09-24 · Software Solutions & Services · Eric Barrera, Life Sciences Consultant at QbD Group
  The EU is revising Annex 11 to align GMP with digital realities. Discover what’s changing and how to prepare for compliance before 2026.

## Regulatory Updates

- [New MDR Updates for Well-Established Technologies](https://qbdgroup.com/en/regulatory-updates/mdr-updates-well-established-technologies-2026) — 2026-07-02 · Regulatory Update · Kirsten Van Garsse
  On 29 June 2026, two new Delegated Regulations amending the MDR (EU) 2017/745 were published, expanding exemptions for well-established medical device technologies from notified body technical documentation assessment and from mandatory cli
- [COMBINE Programme Launches Phase 2 of Coordinated Assessment Pilot](https://qbdgroup.com/en/regulatory-updates/combine-programme-phase-2-coordinated-assessment-pilot) — 2026-06-29 · Regulatory Update · Kirsten Van Garsse
  On 26 June 2026, the European Commission and EU Member States launched Phase 2 of the COMBINE coordinated assessment pilot, expanding the scope to IMP–device, IVD performance, companion diagnostic, and ATMP combined studies, with a rolling 
- [New Harmonised Standards Under MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-mdr-ivdr-2026) — 2026-06-23 · Kirsten Van Garsse
  The European Commission published Implementing Decisions (EU) 2026/1231 and 2026/1313, updating the harmonised standards under the MDR and IVDR. Manufacturers must review impacts on biological evaluation, labelling, electrical equipment, an
- [MDCG Publishes Appendix on Transition to EU REP Symbol](https://qbdgroup.com/en/regulatory-updates/mdcg-appendix-transition-eu-rep-symbol-en-iso-15223-1) — 2026-06-23 · Regulatory Update · Kirsten Van Garsse
  On 17 June 2026, the MDCG published a new Appendix to MDCG 2021-5 Rev.1, guiding manufacturers through the transition from the "EC REP" to the new "EU REP" symbol under EN ISO 15223-1, with a 5-year coexistence period ending 17 June 2031.
- [MDCG Position Paper on Management of SS(C)P in EUDAMED](https://qbdgroup.com/en/regulatory-updates/mdcg-position-paper-management-sscp-ssp-eudamed) — 2026-06-23 · Regulatory Update · Kirsten Van Garsse
  MDCG 2026-4 transfers responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) in EUDAMED to manufacturers, with notified bodies retaining the validation role. Legacy dev
- [New Implementing Regulation (EU) 2026/977 on Uniform Requirements for Conformity Assessment and Notified Bodies](https://qbdgroup.com/en/regulatory-updates/implementing-regulation-eu-2026-977-uniform-requirements-conformity-assessment-notified-bodies) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse
  The European Commission's Implementing Regulation (EU) 2026/977 introduces uniform requirements for notified bodies performing conformity assessments under the MDR and IVDR, setting binding timelines, transparent quotations, and streamlined
- [Updated Manufacturer Incident Report (MIR) Form 7.3.1 Now Mandatory in the EU](https://qbdgroup.com/en/regulatory-updates/updated-manufacturer-incident-report-mir-form-7-3-1-mandatory-eu) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse
  The European Commission's updated Manufacturer Incident Report (MIR) form 7.3.1 is mandatory across the EU since 1 May 2026, introducing new data fields, usability improvements, and updated XSD/XSL files to standardise vigilance reporting u
- [New Harmonised Standards under MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-mdr-ivdr) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse
  The EU has published Commission Implementing Decisions (EU) 2026/193 and (EU) 2026/197, updating harmonised standards under the MDR and IVDR to align with current state of the art and support presumption of conformity with GSPRs.
- [New Harmonised Standards under MDR](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-mdr) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse
  Commission Implementing Decision (EU) 2026/760 updates the list of harmonised standards under the MDR, adding new and revised references that support presumption of conformity.
- [New EU Reference Laboratories for High-Risk IVDs](https://qbdgroup.com/en/regulatory-updates/new-eu-reference-laboratories-high-risk-ivds) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse
  Commission Implementing Regulation (EU) 2025/2526 designates new EU reference laboratories (EURLs) for high-risk IVDs, strengthening IVDR conformity assessment for Class D devices.
- [The BCWG Published Version 5 of the Manual on Borderline and Classification Under MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/bcwg-manual-borderline-classification-mdr-ivdr-v5) — 2026-04-22 · Medical Devices · Kirsten Van Garsse
  On 22 April 2026, the Borderline and Classification Working Group (BCWG) published Version 5 of the Manual on borderline and classification under MDR and IVDR, adding new borderline cases and classification examples agreed under the Helsink
- [MDCG Updates Guidance on Classification of Medical Devices](https://qbdgroup.com/en/regulatory-updates/mdcg-2021-24-rev1-classification-medical-devices-mdr) — 2026-04-20 · Regulatory Update · Kirsten Van Garsse
  On 20 April 2026, the MDCG published Revision 1 of MDCG 2021-24, updating definitions, classification rules, and practical examples to help manufacturers and notified bodies apply MDR classification more consistently.
- [Revision of Q&A on Supply Interruption/Discontinuation Under Article 10a MDR/IVDR](https://qbdgroup.com/en/regulatory-updates/revision-qa-supply-interruption-discontinuation-article-10a-mdr-ivdr) — 2026-04-01 · Regulatory Update · Kirsten Van Garsse
  On 01 April 2026, Revision 2 of the Q&A on the obligation to inform in case of interruption or discontinuation of supply under Article 10a MDR/IVDR, introduced by Regulation (EU) 2024/1860, was published. The update strengthens the link bet
- [ISO 14155:2026 – What You Need to Know](https://qbdgroup.com/en/regulatory-updates/iso-14155-2026-what-you-need-to-know) — 2026-03-30 · Clinical · Delphine Malisse
  ISO 14155:2026, the fourth edition of the international Good Clinical Practice standard for medical device clinical investigations, has been published. It replaces ISO 14155:2020 and sets new requirements for risk management, Clinical Event
- [ICH E2D(R1) – New Expectations for ODCS, PSPs, MRPs & Digital Platforms](https://qbdgroup.com/en/regulatory-updates/ich-e2d-r1-pharmacovigilance-odcs-digital-platforms) — 2026-03-04 · Regulatory Affairs · Almudena del Castillo, Country Manager Spain & Head of Global Vigilance Division at QbD Group
  ICH E2D(R1) introduces new expectations for ODCS, PSPs, MRPs and digital platforms. Learn what MAHs must implement by 18 March 2026 to ensure pharmacovigilance compliance.
- [EMA Framework for the Qualification of Non-Mutagenic Impurities](https://qbdgroup.com/en/regulatory-updates/ema-framework-for-the-qualification-of-non-mutagenic-impurities) — 2026-02-25 · Regulatory Affairs · María José Villarroel
  The European Medicines Agency (EMA) has adopted a Reflection Paper on the Qualification of Non-Mutagenic Impurities (EMA/CHMP/4299/2026), introducing a new scientific framework for the safety assessment of non-mutagenic impurities in medici
- [MDCG on Post-Market Surveillance (PMS) Released](https://qbdgroup.com/en/regulatory-updates/mdcg-2025-10-post-market-surveillance-pms-released) — 2025-12-19 · Regulatory Affairs · Kirsten Van Garsse, Business Unit Manager RA IVD & Representative Services
  On 19 December 2025, MDCG published MDCG 2025-10, clarifying post-market surveillance (PMS) requirements for medical devices and IVDs under MDR and IVDR — emphasising a proactive, lifecycle-wide, QMS-integrated approach.
- [Proposal for a Regulation Amending MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/proposal-for-a-regulation-amending-mdr-and-ivdr) — 2025-12-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 16 December 2025, the European Commission published a Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rule
- [MDCG on Breakthrough Devices Released](https://qbdgroup.com/en/regulatory-updates/mdcg-on-breakthrough-devices-released) — 2025-12-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 15 December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, introducing a streamlined regulatory pathway for Breakthrough Devices (B
- [Draft EU Implementing Act on Notified Body Procedure Published](https://qbdgroup.com/en/regulatory-updates/draft-eu-implementing-act-on-notified-body-procedure) — 2025-12-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 12th 2025 the European Commission has released for consultation the draft Implementing Regulation (EU 2025) laying down certain uniform quality management and procedural requirements for the conformity assessment activities carr
- [MHRA publishes new IVD Roadmap](https://qbdgroup.com/en/regulatory-updates/mhra-publishes-new-ivd-roadmap) — 2025-12-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 15 December 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a new IVD Roadmap, setting out the planned priorities and deliverables for its IVD regulatory programme through mid-2027. This roadmap comp
- [New Update of Appendix 1 of the Nitrosamines Guideline - EMA/42261/2025/Rev. 11](https://qbdgroup.com/en/regulatory-updates/new-update-of-appendix-1-of-the-nitrosamines-guideline-2) — 2025-12-04 · Regulatory Affairs · Pablo Palomar, Senior Toxicology Officer at QbD Group
  On 01/12/2025, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/42261/2025/Rev. 11) of the Nitrosamines Guideline. This appendix lists nitrosamines for which an established Acceptable Intake (AI) is available.
- [EC Confirms 4 EUDAMED Modules Fully Functional](https://qbdgroup.com/en/regulatory-updates/ec-confirms-4-eudamed-modules-fully-functional) — 2025-11-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 27 November 2025, the Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on
- [Team-NB publishes two new Position Papers](https://qbdgroup.com/en/regulatory-updates/team-nb-publishes-two-new-position-papers) — 2025-11-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On October 22nd Team-NB published two new Position Papers. One addresses changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body while the other is a template agreement re
- [Second call for expression of interest in coordinated assessment of clinical investigations / performance studies](https://qbdgroup.com/en/regulatory-updates/second-call-for-expression-of-interest-in-coordinated-assessment-of-clinical-investigations-performance-studies) — 2025-11-17 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under R
- [Adoption of Decision 2025/1324 on expert panels in the field of medical devices](https://qbdgroup.com/en/regulatory-updates/adoption-of-decision-2025-1324-on-expert-panels-in-the-field-of-medical-devices-qbd-group) — 2025-09-30 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 7 July 2025, Commission Implementing Decision (EU) 2025/1324 was published in the Official Journal of the European Union, which amends Implementing Decision (EU) 2019/1396 to streamline certain administrative aspects related to expert pa
- [Adoption of Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application an](https://qbdgroup.com/en/regulatory-updates/adoption-of-commission-delegated-regulation-2025-788) — 2025-09-30 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 28 July 2025, the Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 regarding its application date was adopted. The amendment defers the application of the rules on Unique Device Identifiers (UDI)
- [EU New Variations Guidelines to Streamline Lifecycle Management of Medicines](https://qbdgroup.com/en/regulatory-updates/eu-new-variations-guidelines-to-streamline-lifecycle-management-of-medicines) — 2025-09-30 · Regulatory Affairs · Miguel Gutierrez, Consultant RA Pharma and Peter Fry, Business Unit Manager, RA Pharma & Country Manager, UK, Consultant RA Pharma and Business Unit Manager, RA Pharma & Country Manager, UK
  The European Commission has published the final version of the new Variations Guidelines for human medicines, which will take effect on 15 January 2026 and are designed to support the new Variations Regulation that entered into force in Jan
- [New MDCG position paper released on the timelines of implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lense](https://qbdgroup.com/en/regulatory-updates/new-mdcg-position-paper-released-on-the-timelines-of-implementation-of-master-udi-di) — 2025-09-30 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  The paper explains how the Master UDI-DI solution, introduced through recent Delegated Regulations, is intended to address the high level of individualisation of such devices by grouping them under a common identifier in EUDAMED. This appro
- [Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR](https://qbdgroup.com/en/regulatory-updates/revised-team-nb-position-paper-on-best-practices-for-submission-of-technical-documentation-under-ivdr) — 2025-09-30 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 3 September 2025, the Team-NB published a revised version of their position paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/
- [Update manual on borderline classification IVDR and MDR published](https://qbdgroup.com/en/regulatory-updates/update-manual-on-borderline-classification-ivdr-and-mdr) — 2025-09-30 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 12 September 2025, a new manual on borderline classification IVDR and MDR was published. The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with m
- [EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466](https://qbdgroup.com/en/regulatory-updates/implementing-regulation-eu-2025-1466) — 2025-09-11 · Regulatory Affairs · Almudena del Castillo, Country Manager Spain & Head of Global Vigilance Division at QbD Group
  The European Commission has amended Regulation (EU) No 520/2012 on pharmacovigilance. The update strengthens oversight of outsourced PV activities, clarifies EudraVigilance monitoring, and aligns processes with international data standards 
- [ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation](https://qbdgroup.com/en/regulatory-updates/ich-draft-q3e-guideline-now-open-for-consultation) — 2025-08-13 · Regulatory Affairs · Javier López, Toxicology Expert
  The International Council for Harmonization (ICH) has advanced the long-anticipated Guideline for Extractables and Leachables (Q3E) to Step 2b, initiating the global public consultation phase.
- [Expanded eIFU Eligibility under EU Regulation 2025/1234](https://qbdgroup.com/en/regulatory-updates/expanded-eifu-eligibility-under-eu-regulation-2025-1234) — 2025-07-03 · Regulatory Affairs · QbD Group, Regulatory Affairs
  Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help.
- [FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)](https://qbdgroup.com/en/regulatory-updates/fda-deadline-update-risk-of-nitrosamine-drug-substance-related-impurity) — 2025-07-01 · Regulatory Affairs · Pablo Palomar, Senior Toxicology Officer
  On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities (NDSRIs).
- [4 key guidance documents released under the EU MDR and IVDR frameworks](https://qbdgroup.com/en/regulatory-updates/4-key-guidance-documents-released-under-the-eu-mdr-and-ivdr-frameworks) — 2025-06-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  Last week, the Medical Device Coordination Group (MDCG) released four key guidance documents under the EU MDR and IVDR frameworks, addressing crucial aspects of performance studies, software qualification, and the interplay with the Artific
- [Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment](https://qbdgroup.com/en/regulatory-updates/combine-project-1-pilot) — 2025-06-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 13 June 2025, the European Commission, together with EU Member States and the European Medicines Agency (EMA), launched the first phase of the COMBINE Project 1 pilot—a one-stop, coordinated assessment process for combined clinical trial
- [Nitrosamines Update EMA/409815/2020 Rev.22](https://qbdgroup.com/en/regulatory-updates/nitrosamines-update-rev-22) — 2025-06-02 · Regulatory Affairs · Pablo Palomar, Senior Toxicology Officer
  On 17 May 2025, the European Medicines Agency (EMA) released Revision 22 of its Nitrosamines Q&A document (EMA/409815/2020), bringing key updates for pharmaceutical manufacturers and regulatory professionals.
- [New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released](https://qbdgroup.com/en/regulatory-updates/new-mir-template-and-imdrf-terminologies-for-categorized-adverse-event-reporting-releasedir) — 2025-05-14 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On May 5th, 2025, the European Commission published a new revision of the Manufacturer Incident Report (MIR) template for reporting of serious incidents under Regulation 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). This template will 
- [New UK Clinical Trials Regulations: Key Updates and What They Mean](https://qbdgroup.com/en/regulatory-updates/new-uk-clinical-trials-regulations-key-updates-and-what-they-mean) — 2025-05-05 · Regulatory Affairs · Xi Li, RA Specialist
  On 11th April 2025, the UK Clinical Trial Regulation has been officially signed into law, marking the most significant update in over 20 years. These changes aim to enhance patient safety, expedite approvals, foster innovation, and make it 
- [New Team-NB Position Paper Released on IVDR certification process](https://qbdgroup.com/en/regulatory-updates/new-team-nb-position-paper-released) — 2025-04-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  This Position Paper is a Team-NB consensus document describing the pre-application, application and post-application processes through which manufacturers may apply to Notified Bodies for the certification of in vitro medical devices under 
- [New revision of Team-NB Best Practice Guidance released](https://qbdgroup.com/en/regulatory-updates/new-revision-of-team-nb-best-practice-guidance-released) — 2025-04-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Best Practice Guidance for submitting Technical Documentation under Regulation (EU) 2017/745 (MDR). This third revision 
- [New Revision to MDCG 2020-16 Guidenance Document Released](https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2020-16-guidenance-document-released) — 2025-04-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR). This fourth revision focuses on
- [New revision of Team-NB Position Paper on European AI Act](https://qbdgroup.com/en/regulatory-updates/new-revision-of-team-nb-position-paper-on-european-ai-act) — 2025-04-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Position Paper on the European Artificial Intelligence (AI) Act in relation to Regulation (EU) 2017/745 (MDR) and Regula
- [Fifth revision to MDCG 2019-6 Guidance document released](https://qbdgroup.com/en/regulatory-updates/fifth-revision-to-mdcg-2019-6-guidance-document-released) — 2025-03-05 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On February 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on requirements relating to notified bodies under Regulation (EU) 2017/745 (MDR) and Regul
- [Call for expression of interest in coordinated assessment of clinical investigations/performance studies](https://qbdgroup.com/en/regulatory-updates/call-for-expression-of-interest-in-coordinated-assessment-of-clinical-investigations-performance-studies) — 2025-03-05 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On February 6th, 2025, the EU Member States and the European Commission announced the launch of a pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 201
- [PMS Statutory Instrument + MHRA Guidance released (Great Britain)](https://qbdgroup.com/en/regulatory-updates/pms-statutory-instrument-mhra-guidance-released) — 2025-02-06 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 16 December 2024, the UK enacted the PMS Statutory Instrument, adding Part 4A on post-market surveillance to the Medical Device Regulations 2002. These regulations will come into force following a 6-month transition period on 16 June 202
- [Expert Panel Advice on SARS-CoV-2](https://qbdgroup.com/en/regulatory-updates/expert-panel-advice-on-sars-cov-2) — 2025-02-06 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  The IVD expert panel has issued new scientific advice on SARS-CoV-2, noting that while the virus can still cause severe illness, it no longer poses a life-threatening risk for the general European population. This may influence the classifi
- [New MDCG Guidance documents released](https://qbdgroup.com/en/regulatory-updates/mdcg-on-emdn-codes) — 2025-02-06 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On 28 January 2025, the Medical Device Coordination Group (MDCG) released its first revision of two key documents related to the European Medical Device Nomenclature (EMDN). The updates streamline the process and provide greater clarity on 
- [New revisions of the Preliminary Assessment Review templates, forms and annexes](https://qbdgroup.com/en/regulatory-updates/new-updates-to-mdcg-guidance-document-released) — 2025-01-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On January 10th, 2025, the Medical Device Coordination Group (MDCG) released new revisions of the Preliminary Assessment Review templates and the forms to apply for designation as Notified Body under Regulation (EU) 2017/745 (MDR) or Regula
- [Second revision to MDCG 2023-3 Guidance document released](https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2023-3-guidance-document-released) — 2025-01-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regul
- [New revision to EMA Guidance documents released](https://qbdgroup.com/en/regulatory-updates/new-revision-to-ema-guidance-documents-released) — 2025-01-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 17th, 2024, the European Medicines Agency (EMA) released a revision of 2 guidance documents on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies, designated under Regulation (EU
- [New MDCG 2020-16 Revision 3 Guidance Documents Released](https://qbdgroup.com/en/regulatory-updates/new-mdcg-2020-16-revision-3-guidance-documents-released) — 2025-01-10 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On July 8th, 2024, the Medical Device Coordination Group (MDCG) released its third revision on the guidance for classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG 2020-16 Revision 3).
- [MDCG 2022-3 Rev.1 released](https://qbdgroup.com/en/regulatory-updates/mdcg-2022-3-rev1-released) — 2024-12-24 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 18, 2024, the Medical Device Coordination Group (MDCG) released a revision of the guidance on the verification of manufactured class D IVDs by notified bodies. This guidance document aims to provide clarity regarding the role an
- [Revision of MDCG 2019-13 released](https://qbdgroup.com/en/regulatory-updates/revision-of-mdcg-2019-13-released) — 2024-12-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 17th, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the 2019 guidance on sampling of Regulation (EU) 2017/745 (MDR) Class IIa/Class IIb and Regulation (EU) 2017/746 (IVDR) Class B/Class C devices for 
- [New MDCG 2024-16 form released](https://qbdgroup.com/en/regulatory-updates/new-mdcg-2024-16-form-released) — 2024-12-12 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (MDCG 2024-
- [New MDCG Guidance document released](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-document-released) — 2024-12-09 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. MDCG 2024-15 includes a clarification on the
- [New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-document-released-on-the-implementation-of-the-master-udi-di-solution-for-contact-lenses) — 2024-12-09 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On November 26th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the implementation of the Master UDI-DI solution for contact lenses. Since its amendment by Commission Delegated Regulation (EU) 2023/2197 in Ju
- [New Q&A released on the gradual roll-out of EUDAMED](https://qbdgroup.com/en/regulatory-updates/new-qa-released-on-the-gradual-roll-out-of-eudamed) — 2024-11-26 · EUDAMED · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On November 21st, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the gradual roll-out of EUDAMED. This document provides a Q&A related to the implementation of the gradual roll-out of EUDAMED pursuant to the MDR and IV
- [EMA launched a new draft guideline on risk management requirements for elemental impurities in veterinary medicinal products](https://qbdgroup.com/en/regulatory-updates/ema-launched-a-new-draft-guideline-on-risk-management-requirements-for-elemental-impurities-in-veterinary-medicinal-products) — 2024-11-25 · Toxicology · Sandra Paredes, Quality Assurance Coordinator
  Last October, the EMA launched a new draft for public consultation on the risk assessment of elemental impurities in veterinary products, which will replace the documents currently in effect.
- [MDCG 2023-3 Rev 1 released](https://qbdgroup.com/en/regulatory-updates/mdcg-2023-3-rev-1-released) — 2024-11-15 · regulatory update · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision (MDCG 2023-3 Rev 1) of the questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU
- [MDCG 2024-13 and MDCG 2022-5 Rev 1 released](https://qbdgroup.com/en/regulatory-updates/mdcg-2024-13-and-mdcg-2022-5-rev-1-released) — 2024-11-06 · regulatory affairs · Kirsten Van Garsse, Anne Paulussen, Director AR Services and Manager IVD - RA, Senior Consultant IVD - RA
  On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. In addition, the MDCG released it
- [New Q&A on the obligation to inform in case of interruption or discontinuation of supply](https://qbdgroup.com/en/regulatory-updates/new-qampa-on-the-obligation-to-inform-in-case-of-interruption-or-discontinuation-of-supply) — 2024-11-05 · Regulatory Affairs · Kirsten Van Garsse, Anne Paulussen, Director AR Services and Manager IVD - RA, Senior Consultant IVD - RA
  On October 30th, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the obligation to inform in case of interruption or discontinuation of supply. This document provides a Q&A related to Article 10a as introduced by Regula
- [First Revision of MDCG 2021-25 Released](https://qbdgroup.com/en/regulatory-updates/first-revision-of-mdcg-2021-25-released) — 2024-10-29 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On October 16, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the 'Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021' (MDCG 2021-25). This
- [MDCG 2024-11 released](https://qbdgroup.com/en/regulatory-updates/mdcg-2024-11-released) — 2024-10-14 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On October 8th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on determining which products fall under the scope of Regulation (EU) 2017/746 (IVDR) as in vitro diagnostic medical devices (MDCG 2024-11). It clari
- [MDCG 2024-12 released](https://qbdgroup.com/en/regulatory-updates/mdcg-2024-12-released) — 2024-10-14 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On October 7th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance and templates for the assessment of Corrective and Preventive Action (CAPA) plans, intended for conformity assessment bodies, notified bodies, design
- [Newly Listed Harmonized Standards](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-listed) — 2024-10-14 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union, adopting two new harmonized standards under Regulation (EU) 2017/746 (IVDR) and one unde
- [Revised MDCG 2021-4 Guidance Documents Released](https://qbdgroup.com/en/regulatory-updates/revised-mdcg-guidance-documents-released) — 2024-10-01 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the certification of Class D in vitro diagnostic medical devices under Regulation (EU)
- [The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs](https://qbdgroup.com/en/regulatory-updates/fda-issues-revised-guidance-on-controlling-nitrosamine-impurities-in-human-drugs) — 2024-09-18 · Pharma & Biotech · Pablo Palomar, Senior Toxicology Officer
  The FDA has just released an updated version of its Control of Nitrosamine Impurities in Human Drugs Guidance, introducing crucial changes for pharmaceutical manufacturers.
- [New MDCG Guidance Documents Released](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-documents-released) — 2024-07-12 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On December 21st, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the questions and answers on Articles 13 & 14 on the requirements of importers and distributors of Regulation (EU) 2017/745 and Regulation (
- [Publication of Amendments to Regulation (EU) 2024/1860](https://qbdgroup.com/en/regulatory-updates/publication-of-amendments-to-regulation-eu-2024-1860) — 2024-07-11 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations (EU) 2017/745 or the Medical Device Regulation (MDR) and Regulation (EU) 2017/746 
- [New Update of Appendix 1 of the Nitrosamines Guideline](https://qbdgroup.com/en/regulatory-updates/new-update-of-appendix-1-of-the-nitrosamines-guideline) — 2024-07-09 · Regulatory Affairs · Pablo Palomar, Senior Toxicology Officer
  On 04/07/2024, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/154403/2024 /Rev. 5) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are lis
- [MDCG: First Revision on the Guidance on Standardisation for Medical Devices](https://qbdgroup.com/en/regulatory-updates/mdcg-first-revision-on-the-guidance-on-standardisation-for-medical-devices) — 2024-07-09 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On July 2nd, 2024, the Medical Device Coordination Group (MDCG) released a first revision on the guidance on standardization for medical devices (MDCG 2021-05 Revision 1). This updated guidance provides comprehensive insights into the stand
- [MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies](https://qbdgroup.com/en/regulatory-updates/mdcg-2022-13-rev-1) — 2024-06-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On June 17th, 2024, the Medical Device Coordination Group (MDCG) released a new revision of the guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting assessments of conformity assessme
- [MDCG 2024-10: Clinical Evaluation Guidelines for Orphan Medical Devices](https://qbdgroup.com/en/regulatory-updates/mdcg-2024-10-clinical-evaluation-guidelines-for-orphan-medical-devices) — 2024-06-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On June 25th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10). This document provides guidance to manufacturers and notified bodies on the clinic
- [Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence Repair (MDCG 2024-1-5)](https://qbdgroup.com/en/regulatory-updates/mdcg-2024-1-5-urogynaecological-surgical-mesh-implants-used-for-pelvic-organ-prolapse-repair-and-stress-urinary-incontinence) — 2024-06-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On June 11th, 2024, the Medical Device Coordination Group (MDCG) released a new Device Specific Vigilance guidance (MDCG 2024-1-5 - DSVG 05) for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urina
- [Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2](https://qbdgroup.com/en/regulatory-updates/revision-2-of-mdcg-2022-4-on-mdr-appropriate-surveillance) — 2024-06-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On May 27th, 2024, the Medical Device Coordination Group (MDCG) released a second revision on the guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by cert
- [New MDCG Guidance Documents Released: Key Updates and Insights](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-documents-released-key-updates-and-insights) — 2024-05-27 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. These forms will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessm
- [New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies](https://qbdgroup.com/en/regulatory-updates/new-mdcg-stakeholders-survey-on-mdr-ivdr-certifications-and-applications-released-by-notified-bodies) — 2024-05-27 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  A new survey shows a sharp decline in MDR/IVDR applications and certifications, urging immediate action for compliance before 2025. Stay informed.
- [Latest Update on Appendix 1 of the Nitrosamine Guidelines](https://qbdgroup.com/en/regulatory-updates/latest-update-on-appendix-1-of-the-nitrosamine-guidelines) — 2024-05-14 · Toxicology · Pablo Palomar, Senior Toxicology Officer
  On 01/05/2024, the European Medicines Agency (EMA) rolled out an update to Appendix 1 (EMA/154403/2024 /Rev. 4) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are l
- [EU Parliament Passes Groundbreaking Proposal](https://qbdgroup.com/en/regulatory-updates/eu-parliament-passes-groundbreaking-proposal) — 2024-04-30 · Regulatory Updates · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations 2017/745 MDR, and 2017/746 IVDR as regards a gradual roll-out of Eudamed, information o
- [New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products](https://qbdgroup.com/en/regulatory-updates/new-ema-guideline-on-environmental-risk-assessment-for-human-medicinal-products) — 2024-04-23 · Environmental Risk Assessment · María José Villarroel, Toxicology & Quality Director
  New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and set to come into effect on September 1, 2024, stipulates that an ERA report will be
- [New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-investigators-brochure-content-for-clinical-investigations-of-medical-devices) — 2024-04-22 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices under Regulation (EU) 2017/745 or the medical device
- [New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-safety-reporting-for-performance-studies-of-in-vitro-diagnostic-medical-devices-under-eu-regulation-2017-746-released) — 2024-04-22 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) as per Article 76(2) of Regulation (EU) 2017/746 – I
- [New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-updating-the-european-medical-device-nomenclature-emdn) — 2024-03-15 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU)
- [New MDCG Guidance Released: Device-Specific Vigilance Document](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-released-device-specific-vigilance-document) — 2024-03-15 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices. This document outlines the way to report
- [New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies](https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-released-detailed-instructions-for-clinical-investigation-plans-in-medical-device-studies) — 2024-03-15 · MDCG · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  This guidance document, developed by contributions from national competent authorities, industry, and relevant stakeholders, aims to support sponsors of Clinical Investigation Plans (CIPs) in medical device studies by detailing the informat
- [Newly Published Harmonized Standards for MDR and IVDR Compliance](https://qbdgroup.com/en/regulatory-updates/newly-published-harmonized-standards-for-mdr-and-ivdr-compliance) — 2024-03-14 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  New harmonized standards for MDR and IVDR provide essential technical requirements to support compliance for medical devices and IVDs in the EU market.
- [Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions](https://qbdgroup.com/en/regulatory-updates/proposed-amendments-to-ivdr-and-mdr-transitional-provisions-eudamed-roll-out-and-supply-chain-interruptions) — 2024-02-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.
- [EU Council Endorses Proposal to Amend IVDR and MDR Regulations](https://qbdgroup.com/en/regulatory-updates/eu-council-endorses-proposal-to-amend-ivdr-and-mdr-regulations) — 2024-02-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR, introducing an extension of the transitional provisions for certain in vitro diagnostic medical devices and a gradual roll-out of 
- [New EMA FAQ on medicinal products development and assessment involving a CDx](https://qbdgroup.com/en/regulatory-updates/new-ema-faq-on-medicinal-products-development-and-assessment-involving-a-cdx) — 2024-01-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation.
- [Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers](https://qbdgroup.com/en/regulatory-updates/comprehensive-overview-of-language-requirements-under-ivdr-mdr-for-medical-device-manufacturers) — 2024-01-23 · Regulatory Affairs · Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
  EU Commission publishes language requirement tables for MDR and IVDR to help medical device manufacturers meet language compliance across EU Member States.

## White Papers

- [Designing Orthopaedic Clinical Evidence for Europe](https://qbdgroup.com/en/whitepapers/designing-orthopaedic-clinical-evidence-europe) — 2026-09-04 · Clinical · Laura Drikite & Caroline Aernouts
  Orthopaedic clinical development presents distinct challenges. Outcomes depend not only on the device, but also on surgical technique, implant mechanics, patient anatomy, rehabilitation and long-term functional recovery. This whitepaper sho
- [First-In-Human Readiness Guide for Early-stage Biotechs](https://qbdgroup.com/en/whitepapers/first-in-human-readiness-guide-early-stage-biotechs) — 2026-08-12 · Regulatory Affairs · Angeles Escartí-Nebot
  First-in-Human (FIH) is not the finish line of preclinical work, it's the foundation everything else builds on. The dose you select, the manufacturing process you lock in, and the operational setup you put in place now will decide whether y
- [Extractables & Leachables in Pharma](https://qbdgroup.com/en/whitepapers/extractables-leachables-pharma-ich-q3e) — 2026-08-06 · Quality Assurance · Javier López
  The draft ICH Q3E guideline is the first harmonized global framework dedicated specifically to Extractables & Leachables (E&L) in pharmaceuticals and biologics. With final adoption expected by 2027, this whitepaper breaks down what the guid
- [Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials](https://qbdgroup.com/en/whitepapers/ai-sae-susar-management-clinical-trials) — 2026-07-08 · Clinical · Anam Ahmad
  Clinical trial safety teams are under increasing pressure. Larger global studies, decentralised trials and growing volumes of safety data make timely SAE and SUSAR management more complex than ever. Artificial Intelligence offers powerful o
- [A Complete Roadmap for US Biotechs Entering the EU/UK Market](https://qbdgroup.com/en/whitepapers/roadmap-us-biotechs-eu-uk-market) — 2026-06-08 · Regulatory Affairs · Angeles Escartí-Nebot
  US biotech ready to expand into Europe? This whitepaper walks you through the four critical stages of EU/UK market entry, from choosing the right regulatory pathway to building operational readiness on the ground.
- [Innovations in ATMP: State of the Art in 2026](https://qbdgroup.com/en/whitepapers/innovations-in-atmp-state-of-the-art-2026) — 2026-06-03 · Regulatory Affairs · QbD Group
  A comprehensive overview of the state of the art in Advanced Therapy Medicinal Products (ATMPs) as of June 2026 — covering EU regulation, cutting-edge manufacturing, evolving quality standards, and the business strategies shaping the future
- [Scaling Pharmacovigilance in Europe](https://qbdgroup.com/en/whitepapers/scaling-pharmacovigilance-europe) — 2026-05-21 · Pharmacovigilance · Almudena del Castillo, Division Head Vigilance
  As pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compl
- [Home Market Approval ≠ EU Readiness](https://qbdgroup.com/en/whitepapers/home-market-approval-eu-readiness) — 2026-04-15 · Regulatory Affairs · Petra De Geest & Anne-Sophie Grell
  FDA or NMPA approval doesn't mean EU readiness. Learn why home market success often leads to delays under EU MDR, and how to avoid them.
- [Sponsor Responsibilities in IVD Clinical Performance Studies](https://qbdgroup.com/en/whitepapers/sponsor-responsibilities-ivd-performance-studies) — 2026-03-30 · Clinical · Annelies Rotthier & Kirsten Van Garsse
  Understand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models.
- [Annex 1 Compliance Signals from FDA Warning Letters](https://qbdgroup.com/en/whitepapers/annex-1-compliance-signals-fda-warning-letters) — 2026-03-13 · Quality Assurance · Jo Doucet & Stan Van Kerkhoven
  What do 230 FDA warning letters reveal about recurring sterile manufacturing deficiencies? This white paper analyses inspection findings from 2023–2025 and maps them to EU GMP Annex 1 expectations, revealing where manufacturers most frequen
- [Optimizing APR-PQR for Compliance and Efficiency](https://qbdgroup.com/en/whitepapers/optimizing-apr-pqr-compliance-efficiency) — 2025-12-16
  Discover practical ways to streamline APR/PQR, reduce QA workload, and improve compliance through better data, templates, digital tools, and external support.
- [Cleaning Validation in Pharma](https://qbdgroup.com/en/whitepapers/cleaning-validation-in-pharma) — 2025-12-15
  Learn how risk-based cleaning validation, HBELs, and modern analytical methods help ensure compliant, contamination-free pharmaceutical manufacturing. Download the whitepaper.
- [The Essential CSV & Digitalization FAQ for Life Sciences Companies](https://qbdgroup.com/en/whitepapers/the-essential-csv-digitalization-faq) — 2025-10-28
  Get clear answers to real CSV questions from clients & experts. Download our FAQ and stay compliant, audit-ready, and confident in your Software Validation Strategy.
- [Digitalization in the Pharmaceutical Industry: And How to Stay Compliant](https://qbdgroup.com/en/whitepapers/digitalization-in-the-pharmaceutical-industry) — 2025-10-07
  Digitalization and Pharma 4.0 drive digital transformation. Explore the role of CSV in pharma's digital journey.
- [Audit Trail Review in GxP Environments](https://qbdgroup.com/en/whitepapers/audit-trail-review-in-gxp-environments) — 2025-07-03
  Learn how to implement a risk-based Audit Trail review strategy to enhance software compliance in GxP environments.
- [A Complete Guide to Computer System Validation](https://qbdgroup.com/en/whitepapers/a-complete-guide-to-computer-system-validation) — 2025-04-30
  This guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems. Download now.
- [Digital Health - Exploring the landscape and future opportunities](https://qbdgroup.com/en/whitepapers/e-book-digital-health-exploring-the-landscape-and-future-opportunities) — 2025-04-30
  This whitepaper informs you about digital health, key technology pillars, and new opportunities to anticipate future trends in your healthcare sector.
- [ICH Stability Studies: Safeguarding Quality & Shelf Life of Pharmaceuticals](https://qbdgroup.com/en/whitepapers/ich-stability-studies-on-pharmaceuticals) — 2025-03-13
  How do you ensure a pharmaceutical product remains safe, effective and within specification throughout its shelf life? Discover how to design and conduct robust stability studies in line with ICH and regulatory requirements.
- [EU GMP: Import of Medicinal Products](https://qbdgroup.com/en/whitepapers/whitepaper-eu-gmp) — 2025-03-12 · Pharma & Biotech
  Bringing medicinal products into the EU involves much more than getting them across the border. Discover the GMP requirements, responsibilities and practical considerations behind importing medicines from third countries into the EU. Naviga
- [How to Keep Computerized Systems in the Operational Phase](https://qbdgroup.com/en/whitepapers/how-to-keep-computerized-systems-in-the-operational-phase) — 2025-03-03 · Software Services & Solutions
  Validation doesn’t stop when a computerized system goes live. Discover the key practices for keeping your systems validated, reliable and secure throughout the operational phase. Learn how to maintain compliance, data integrity and operatio
- [Regulatory Affairs for Pharma and Biotech](https://qbdgroup.com/en/whitepapers/regulatory-affairs-for-pharma-and-biotech) — 2025-01-06
  In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.
- [Clinical Evaluation for Medical Devices Under MDR](https://qbdgroup.com/en/whitepapers/clinical-evaluation-for-medical-devices-under-mdr) — 2025-01-05 · Clinical
  Clinical evaluation is central to demonstrating the safety, performance and clinical benefits of your medical device under the MDR. Discover how to build a robust clinical evaluation strategy, prepare your CEP and CER, and generate the clin
- [IVDR Extension: What Does This Mean for You?](https://qbdgroup.com/en/whitepapers/ivdr-extension-what-does-this-mean-for-you) — 2025-01-01 · Regulatory Affairs
  The IVDR transition timelines have been extended, but that does not mean manufacturers can put compliance on hold. Discover what Regulation (EU) 2024/1860 means for your IVD portfolio, which requirements and deadlines you need to consider, 
- [State-of-the-Art Literature Review: Kick Off the Clinical Evaluation of Your Medical Device](https://qbdgroup.com/en/whitepapers/state-of-the-art-literature-review) — 2024-12-23
  A solid clinical evaluation starts with a solid understanding of the state of the art. For medical device manufacturers, a State-of-the-Art (SOTA) literature review is a crucial part of the clinical evaluation process and a requirement for 
- [Mobile Health on the Rise: Exploring the Regulatory Landscape for Reimbursement](https://qbdgroup.com/en/whitepapers/mobile-health-on-the-rise-exploring-the-regulatory-landscape-for-reimbursement) — 2024-12-11
  Digital therapeutics are transforming healthcare, but bringing a DTx solution to patients involves much more than developing the technology. From CE marking and clinical evidence to country-specific reimbursement pathways, the regulatory la
- [Clinical Investigations Under MDR](https://qbdgroup.com/en/whitepapers/clinical-investigations-under-mdr) — 2024-12-10
  The EU MDR has brought greater consistency to clinical investigations, but navigating the process across Member States is still far from straightforward. From regulatory pathways and ethics approvals to tight timelines and post-market requi
- [Medical Devices: The Pathway From Idea to Patient Under MDR](https://qbdgroup.com/en/whitepapers/pathway-from-idea-to-patient) — 2024-12-10
  Bringing a medical device from idea to patient takes more than a great concept. Every decision along the way can impact your regulatory pathway, clinical strategy and route to market. This white paper guides you through the key steps of the
- [GAMP 5 Software Validation for GMP, GCP and GLP](https://qbdgroup.com/en/whitepapers/gamp-5-software-validation-approach-for-gmp-gcp-and-glp-regulations) — 2024-11-19
  Computerized systems are everywhere in life sciences, but the regulatory requirements surrounding them differ across manufacturing, clinical and laboratory environments. So how do you build a validation approach that works across GMP, GCP a
- [Standards and Regulations for Software Used in Medical Devices](https://qbdgroup.com/en/whitepapers/standards-and-regulations-for-software-used-in-medical-devices) — 2024-11-12
  Learn how IEC 62304, IEC 82304 and ISO 13485 fit together and which standards matter for your medical device software.
- [Clinical evidence for In Vitro Diagnostics under IVDR](https://qbdgroup.com/en/whitepapers/clinical-evidence-for-in-vitro-diagnostics-under-ivdr) — 2024-11-11
  In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.
- [Achieving Laboratory Compliance](https://qbdgroup.com/en/whitepapers/achieving-laboratory-compliance) — 2024-11-05
  Reliable laboratory results start with more than the right equipment. They depend on qualified instruments, validated methods, robust data integrity practices and a quality system that brings it all together. This white paper provides a pra
- [The One-Vigilance® Strategic Roadmap to Corporate Excellence](https://qbdgroup.com/en/whitepapers/the-one-vigilance-strategic-roadmap-to-corporate-excellence) — 2024-11-04
  Pharmacovigilance is evolving beyond compliance. New therapies, real-world data and digital innovation are changing how safety teams detect risks, protect patients and create strategic value. Discover the One-Vigilance® approach to building
- [New GMP Facility Qualification](https://qbdgroup.com/en/whitepapers/new-gmp-facility-qualification-set-up-process-best-practices) — 2024-11-04
  Setting up a new GMP facility is a complex journey where every decision can impact compliance, timelines and costs. From facility design to qualification and project execution, getting it right from the start matters. Discover the key steps
- [Annual Product Quality Review in Pharma](https://qbdgroup.com/en/whitepapers/annual-product-quality-review-in-pharma) — 2024-11-04
  An Annual Product Quality Review is more than a regulatory requirement. Done well, it reveals trends, risks and opportunities to improve both product quality and manufacturing performance. Discover how to turn your APQR/PQR into a valuable 
- [Ensuring Compliance and Quality in Pharmacovigilance](https://qbdgroup.com/en/whitepapers/ensuring-compliance-and-quality-in-pharmacovigilance) — 2024-10-14
  In pharmacovigilance, being compliant isn't enough. You need to be able to demonstrate it, at any time. Discover how to build a robust pharmacovigilance quality system, prepare for audits and inspections, manage non-conformities and keep pa
- [Organic and Mutagenic Impurities in Pharma](https://qbdgroup.com/en/whitepapers/organic-and-mutagenic-impurities-in-pharma) — 2024-10-09
  Even trace levels of impurities can affect the safety and quality of a medicinal product. Identifying them is only the first step; understanding their toxicological risk and defining safe limits is just as critical. Discover how to assess a
- [The Key Role of Regulatory Affairs in the Pharmaceutical Industry](https://qbdgroup.com/en/whitepapers/the-key-role-of-regulatory-affairs-in-the-pharmaceutical-industry-from-drug-development-to-commercialization) — 2024-10-08
  Regulatory Affairs is about much more than getting a medicinal product approved. Discover where RA adds value across the product lifecycle and why early involvement matters.
- [GAMP categories for computerized systems](https://qbdgroup.com/en/whitepapers/gamp-categories-for-computerized-systems) — 2024-10-01
  Not all computerized systems require the same validation approach. GAMP categories help you classify systems by complexity and focus your validation efforts where the risks are greatest. Discover what each category means and how it can guid
- [Analytical Method Validation](https://qbdgroup.com/en/whitepapers/analytical-method-validation-qualval) — 2024-09-25
  Reliable analytical results start with a method that is fit for purpose. But how do you demonstrate that your method consistently delivers the accuracy, precision and reliability you need? Discover the key characteristics to consider when v
- [From V-model to Agile: How to Embrace Automation as Part of the Computerized System Validation Approach](https://qbdgroup.com/en/whitepapers/from-v-model-to-agile) — 2024-09-16
  Computerized System Validation doesn't have to stand in the way of Agile software development. Discover how to combine Agile flexibility with the assurance and control regulated systems demand.
- [Innovations in ATMP: State of the Industry in 2024](https://qbdgroup.com/en/whitepapers/innovations-in-atmp-state-of-the-industry-in-2024) — 2024-08-12
  Advanced Therapy Medicinal Products are transforming what is possible in healthcare. From CAR T-cell therapy and CRISPR-Cas9 to new approaches in manufacturing and quality, innovation is moving fast. Discover the key developments shaping th

## Checklists

- [ISO 13485:2016 - Compliance Checklist](https://qbdgroup.com/en/downloads/checklists/checklist-iso-134852016) — 2025-04-17
  Are you up to date with the latest medical device QMS requirements? Download our free ISO 13485:2016 checklist to ensure compliance.
- [Medical Device Regulation (MDR) Checklist](https://qbdgroup.com/en/downloads/checklists/mdr-checklist) — 2025-02-26
  Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.
- [21 CFR Part 11 Checklist and Questionnaire](https://qbdgroup.com/en/downloads/checklists/21-cfr-part-11-checklist-and-questionnaire) — 2024-10-15
  Electronic records and signatures come with strict regulatory requirements. But does your system actually meet them? Use this practical checklist to assess your computer system against key 21 CFR Part 11 requirements and quickly identify po
- [EudraLex Volume 4 Annex 11 Compliance Checklist](https://qbdgroup.com/en/downloads/checklists/eudralex-volume-4-annex-11-compliance-checklist) — 2024-09-17
  How confident are you that your computerized systems meet the requirements of EU GMP Annex 11? Use this practical checklist to review the key compliance areas and identify potential gaps.

## Case Studies

- [Landing in Europe: Techdow's EU Market Entry](https://qbdgroup.com/en/case-studies/techdow-eu-market-entry) — 2026-07-22
  Discover how QbD Group helped Techdow Pharmaceutical, a leading global pharmaceutical company supplying complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe.
- [Landing in Europe: Henlius's EU Market Entry](https://qbdgroup.com/en/case-studies/henlius-eu-market-entry) — 2026-06-03
  Discover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant.
- [Scaling a Global Pharmacovigilance Model for International Growth](https://qbdgroup.com/en/case-studies/scalable-pharmacovigilance-model-global-growth) — 2026-05-06
  Discover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance.
- [Building a Global Pharmacovigilance Framework for Seamless EU Entry and Worldwide Expansion](https://qbdgroup.com/en/case-studies/global-pharmacovigilance-framework-eu-expansion) — 2026-05-06
  Discover how QbD Group helped a Chinese biopharmaceutical company build a scalable global pharmacovigilance framework for EU entry and worldwide expansion.
- [GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software](https://qbdgroup.com/en/case-studies/gmp-support-for-closing-capas-across-qa-qualval-and-software) — 2026-02-03
  Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.
- [Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access](https://qbdgroup.com/en/case-studies/multiplex-respiratory-antigen-test-accelerating-ivdr-market-access) — 2025-08-19
  Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.
- [Building a Unified QMS for a Non-Profit Lab Organization](https://qbdgroup.com/en/case-studies/building-a-unified-qms-for-a-non-profit-lab-organization) — 2025-08-06
  A non-profit lab organization unified its quality management processes by implementing a validated SAAS QMS, enhancing compliance and efficiency across departments.
- [Agile Validation Support for a Global Life Sciences Organization](https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization) — 2025-08-06
  Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.
- [Faster Market Entry Through Integrated IVDR and WHO Strategy](https://qbdgroup.com/en/case-studies/faster-market-entry-through-integrated-ivdr-and-who-strategy) — 2025-08-05
  Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.
- [Multiplex STI PCR Test: Supporting a Smooth IVDR Journey](https://qbdgroup.com/en/case-studies/multiplex-sti-pcr-test-supporting-a-smooth-ivdr-journey) — 2025-07-29
  Learn how we supported a global IVD manufacturer in achieving IVDR compliance for their multiplex STI PCR test, ensuring timely CE-marking and future regulatory confidence.
- [Validating a Complex Autoclave Load to Enhance Sterilization Efficiency](https://qbdgroup.com/en/case-studies/autoclave-load-validation-barcelona) — 2025-05-28
  Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.
- [Fast-Tracked Site Qualification for Clinical Trial Submission](https://qbdgroup.com/en/case-studies/clinical-site-qualification) — 2025-05-21
  QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.
- [Enhancing data integrity & aseptic manufacturing compliance](https://qbdgroup.com/en/case-studies/enhancing-data-integrity-aseptic-manufacturing-compliance) — 2025-04-07
  QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.
- [A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader](https://qbdgroup.com/en/case-studies/linguistic-review-support-for-a-global-pharma-leader) — 2025-04-01
  QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.
- [Restoring manufacturing timelines through expert deviation management](https://qbdgroup.com/en/case-studies/deviation-management-timely-batch-release) — 2025-03-05
  Discover how QbD Group helped a leading biotechnology company overcome a backlog of deviations, restoring timely batch release through expert QA support.
- [Guiding a global biotech company through ATMP facility qualification](https://qbdgroup.com/en/case-studies/atmp-production-sites-commissioning-qualification) — 2025-03-05
  Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.
- [Supporting Market Access to Essential Medicines in Europe](https://qbdgroup.com/en/case-studies/supporting-market-access-to-essential-medicines-in-europe) — 2025-03-05
  Support your entry into the European pharmaceutical market with expert regulatory guidance, ensuring compliance and access to essential medicines for patients. Contact us today for assistance.
- [Scalable MSAT validation support for seamless compliance & efficiency](https://qbdgroup.com/en/case-studies/msat-validation-project) — 2025-03-05
  Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.
- [CE Mark Renewal for bioXtra Products: A Success Story](https://qbdgroup.com/en/case-studies/ce-mark-renewal-lifestream-pharma-bioxtra) — 2024-12-04
  Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
- [Guiding KU Leuven's glioblastoma research to the clinic with precision business planning](https://qbdgroup.com/en/case-studies/guiding-ku-leuvens-glioblastoma-research-to-the-clinic-with-precision-business-planning) — 2024-10-30
  Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.
- [Optimizing pharmacovigilance for a biotechnology leader](https://qbdgroup.com/en/case-studies/optimizing-pharmacovigilance-for-a-biotechnology-leader) — 2024-06-28
  Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.
- [Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line](https://qbdgroup.com/en/case-studies/ensuring-timely-launch-qbd-groups-role-in-establishing-a-hemophilia-drug-production-line) — 2024-06-27
  QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.
- [Ensuring pharmaceutical production quality: cleaning validation for government agency](https://qbdgroup.com/en/case-studies/ensuring-pharmaceutical-production-quality-cleaning-validation-for-government-agency) — 2024-05-31
  Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.
- [Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration](https://qbdgroup.com/en/case-studies/revolutionizing-pharmacovigilance-a-success-story-of-strategic-partnership-and-seamless-integration) — 2024-05-31
  Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).
- [The journey toward IVDR compliance for the LVOne device](https://qbdgroup.com/en/case-studies/the-journey-toward-ivdr-compliance-for-the-lvone-device) — 2024-05-29
  QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
- [Patient Support Program (PSP)](https://qbdgroup.com/en/case-studies/patient-support-program-psp) — 2024-04-16
  Learn about our patient support program (PSP) and how it helps manage customer support for a PV Spanish client. Resolve quality issues and ensure stability with QbD Pharma.
- [Ensuring a smooth MDR transition for Oystershell's medical devices](https://qbdgroup.com/en/case-studies/ensuring-a-smooth-mdr-transition-for-oystershells-medical-devices) — 2024-03-25
  The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges in
- [Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter](https://qbdgroup.com/en/case-studies/successful-clinical-evaluation-supports-rapid-ce-marking-of-minze-healths-uroflowmeter) — 2023-11-01
  QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
- [Helping Relu to comply with changing regulations](https://qbdgroup.com/en/case-studies/helping-relu-to-comply-with-changing-regulations) — 2022-12-06
  QbD Group supported software company Relu with their expertise to comply with changing regulations.
- [Helping Abraca BioSystems to obtain ISO 13485 certification](https://qbdgroup.com/en/case-studies/helping-abraca-biosystems-to-obtain-iso-13485-certification) — 2022-06-16
  QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
- [Help BioLizard build their Quality Management System](https://qbdgroup.com/en/case-studies/help-biolizard-build-their-quality-management-system) — 2021-08-17
  QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.
- [Supporting Oncomfort in developing and certifying their ISO 13485 QMS](https://qbdgroup.com/en/case-studies/supporting-oncomfort-in-developing-and-certifying-their-iso-13485-qms) — 2021-06-30
  QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.
- [Quickly bringing a new COVID-19 medical device to market](https://qbdgroup.com/en/case-studies/quickly-bringing-a-new-covid-19-medical-device-to-market) — 2021-04-11
  Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

## Webinars

- [Clinical Evidence for SaMDs (IVD)](https://qbdgroup.com/en/webinars/clinical-evidence-for-samds-ivd-on-demand) — 2026-09-10 · Clinical Solutions
  For SaMDs classified as (part of) an IVD, scientific validity, analytical performance, and performance evaluation challenge classical clinical evidence gathering. In this webinar, we'll guide you through the 'how,' based on QbD Group's real
- [Estrategia de Control de Contaminación (CCS): cómo alinear QC, QA y Regulatory ante una inspección](https://qbdgroup.com/en/webinars/ccs-qc-qa-regulatory-control-contaminacion-anexo-1) — 2026-09-08 · Quality Assurance · Rodrigo Mondelo Ripoll
  Descubre cómo QC, QA y Regulatory construyen juntos un CCS sólido y defendible bajo el Anexo 1 de las EU GMP, y qué espera ver un inspector en 2026.
- [Regulatory Evolution: What AI Means for GMP Manufacturing](https://qbdgroup.com/en/webinars/regulatory-evolution-what-ai-means-for-gmp-manufacturing-on-demand) — 2026-09-08 · Software Solutions & Services
  A practical, inspector-informed look at what deploying AI in GMP-regulated environments really means: validation, human oversight, auditability, explainability, and the ongoing monitoring that traditional CSV was never designed for.
- [IVDR & WHO Requirements for Clinical Performance: With a focus on HPV studies](https://qbdgroup.com/en/webinars/ivdr-who-requirements-hpv-studies) — 2026-08-18 · Clinical
  How to navigate combined IVDR and WHO PQ requirements and reach regulator-ready execution grounded in a real-world HPV case study and multi-site clinical execution across Africa.
- [Más allá del mapeo térmico: justificación de las variaciones de temperatura y su impacto en los productos](https://qbdgroup.com/en/webinars/mapeo-termico-justificacion-variaciones-temperatura-impacto-productos-farmaceuticos) — 2026-07-28
  Las excursiones de temperatura representan uno de los desafíos más frecuentes y complejos en el almacenamiento y distribución de medicamentos. Este webinar entrega criterios técnicos, regulatorios y prácticos para evaluar su impacto sobre l
- [Wellness App vs. Medical Device: Which Side Are You Really On?](https://qbdgroup.com/en/webinars/wellness-app-vs-medical-device) — 2026-07-23 · Software Solutions & Services
  Is your software a wellness app, or a regulated medical device under EU MDR? It's one of the most common questions we receive from digital health founders, software teams, and scale-ups preparing for European market entry. Getting the answe
- [Clinical Evidence for SaMDs (IVD)](https://qbdgroup.com/en/webinars/clinical-evidence-for-samds-ivd) — 2026-07-22 · Clinical Solutions
  For SaMDs classified as (part of) an IVD, scientific validity, analytical performance, and performance evaluation challenge classical clinical evidence gathering. In this webinar, we'll guide you through the 'how,' based on QbD Group's real
- [The Future of Medical Information (MI)](https://qbdgroup.com/en/webinars/the-future-of-medical-information) — 2026-07-22 · Pharmacovigilance
  Medical Information is shifting from an operational to a strategic function. Explore how AI, rising inquiry complexity, and tighter MI-PV integration expectations are reshaping the MI landscape, and what your team should do about it.
- [Regulatory Evolution: What AI Means for GMP Manufacturing](https://qbdgroup.com/en/webinars/regulatory-evolution-what-ai-means-for-gmp-manufacturing) — 2026-07-08 · Software Solutions & Services
  A practical, inspector-informed look at what deploying AI in GMP-regulated environments really means: validation, human oversight, auditability, explainability, and the ongoing monitoring that traditional CSV was never designed for.
- [Entering the European MedTech Market: Why One Approval Doesn't Fit All (Chinese)](https://qbdgroup.com/en/webinars/webinar-on-demand-entering-the-european-medtech-market-chinese) — 2026-07-08 · Medical Devices
  On-demand webinar (Chinese) — mirror of the English EU MedTech market entry webinar.
- [Entering the European MedTech Market: Why One Approval Doesn't Fit All (Chinese)](https://qbdgroup.com/en/webinars/entering-the-european-medtech-market-chinese) — 2026-07-08 · Medical Devices
  On-demand webinar (Chinese) — mirror of the English EU MedTech market entry webinar.
- [Managing Lifecycle Complexity: Controlling Compliance Risk and Operational Pressure Across Regulatory and Pharmacovigilance](https://qbdgroup.com/en/webinars/managing-lifecycle-complexity-regulatory-pharmacovigilance-on-demand) — 2026-06-26 · Regulatory Affairs · QbD Group
  Watch the on-demand recording: Dr. Almudena del Castillo and Joanna Rapacz explore how growing portfolios, acquisitions, and market expansion increase operational complexity across Regulatory Affairs and Pharmacovigilance — and how integrat
- [Environmental Risk Assessments (ERA): From Regulatory Requirements to Submission-Ready Strategies](https://qbdgroup.com/en/webinars/webinar-on-demand-environmental-risk-assessments-regulatory-submission-ready-strategies) — 2026-05-29 · Quality Assurance
  Understand how to translate ERA regulatory expectations into a robust, science-based and submission-ready approach. Learn how to avoid common pitfalls, optimize data requirements and build a defensible Environmental Risk Assessment aligned 
- [EU-GMP Readiness and Supply Chain Strategies for Chinese Pharma](https://qbdgroup.com/en/webinars/eu-gmp-readiness-supply-chain-strategies-chinese-pharma-on-demand) — 2026-05-20
- [Getting an Oncology IVD to Market Faster: What Founders Underestimate Early On](https://qbdgroup.com/en/webinars/oncology-ivd-market-faster-what-founders-underestimate-on-demand) — 2026-05-20 · Clinical
  Watch the on-demand recording: Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
- [Managing Lifecycle Complexity: Controlling Compliance Risk and Operational Pressure Across Regulatory and Pharmacovigilance](https://qbdgroup.com/en/webinars/managing-lifecycle-complexity-regulatory-pharmacovigilance) — 2026-05-18 · Regulatory Affairs · QbD Group
  As pharmaceutical organizations grow and evolve, Lifecycle Management becomes increasingly difficult to control. This webinar explores how complexity develops across Regulatory Affairs and Pharmacovigilance, and how to structure activities 
- [EU-GMP Readiness and Supply Chain Strategies for Chinese Pharma](https://qbdgroup.com/en/webinars/eu-gmp-readiness-supply-chain-strategies-chinese-pharma) — 2026-05-08 · Pharma & Biotech · Marta Klepczyńska & Joanna Rapacz
  A practical guide for Chinese manufacturers preparing for EU market access. Request the recording to learn how EU-GMP requirements, inspections, and supply chain design impact registration timelines and launch readiness.
- [BPL y BPM: Estrategias para blindar el cumplimiento y evitar hallazgos críticos en auditoría](https://qbdgroup.com/en/webinars/bpl-bpm-estrategias-blindar-cumplimiento-hallazgos-criticos-auditoria) — 2026-05-05 · Victoria Armenta
  Descubre el enfoque BxP para alinear BPL y BPM, cerrar brechas técnicas entre laboratorio y planta, y blindar el cumplimiento ante hallazgos críticos en auditorías regulatorias.
- [Entering the European MedTech Market: Why One Approval Doesn't Fit All](https://qbdgroup.com/en/webinars/webinar-on-demand-entering-the-european-medtech-market-why-one-approval-doesnt-fit-all) — 2026-05-04 · Medical Devices
  This webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, N
- [EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation](https://qbdgroup.com/en/webinars/webinar-on-demand-eu-gmp-annex-1-implementation-regulatory-expectations-practical-remediation) — 2026-05-04 · Quality Assurance
  This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen susta
- [Environmental Risk Assessments (ERA): From Regulatory Requirements to Submission-Ready Strategies](https://qbdgroup.com/en/webinars/environmental-risk-assessments-regulatory-submission-ready-strategies) — 2026-04-20 · Quality Assurance
  Understand how to translate ERA regulatory expectations into a robust, science-based and submission-ready approach. Learn how to avoid common pitfalls, optimize data requirements and build a defensible Environmental Risk Assessment aligned 
- [Getting an Oncology IVD to Market Faster: What Founders Underestimate Early On](https://qbdgroup.com/en/webinars/oncology-ivd-market-faster-what-founders-underestimate) — 2026-04-14 · Clinical
  In this 60-minute session, Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
- [Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space](https://qbdgroup.com/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space-on-demand) — 2026-04-10 · Regulatory Affairs
  Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD m
- [Mapeo Térmico: Cómo defender el reporte y actuar cuando los resultados no cumplen](https://qbdgroup.com/en/webinars/mapeo-termico-como-defender-el-reporte-para-el-cumplimiento-normativo) — 2026-04-07
  El mapeo térmico no finaliza con la obtención de los datos, sino con su análisis técnico y la correcta documentación de los resultados. Este webinar tiene como objetivo brindar a los participantes criterios prácticos para elaborar reportes 
- [EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation](https://qbdgroup.com/en/webinars/eu-gmp-annex-1-implementation-regulatory-expectations-practical-remediation) — 2026-03-19 · Quality Assurance
  This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen susta
- [AI in Life Sciences](https://qbdgroup.com/en/webinars/ai-in-life-sciences-gxp-compliance) — 2026-03-19 · Life Sciences · Jonathan Boel, Division Head Software Solutions & Services at QbD Group, Evelien Cools, Industry Lead Life Sciences at delaware, CSV & Data Integrity Consultant at QbD Group, Pieter Smits, Project Manager at QbD Group
  Leveraging AI in life sciences is powerful, but also complex under GxP. In this joint webinar, QbD Group and delaware show how to implement AI in a trustworthy, validated, and inspection-ready way, with the right approach to data, explainab
- [AI in Life Sciences](https://qbdgroup.com/en/webinars/ai-in-life-sciences-gxp-compliance-on-demand) — 2026-03-19 · Life Sciences · Jonathan Boel, Division Head Software Solutions & Services at QbD Group, Evelien Cools, Industry Lead Life Sciences at delaware, CSV & Data Integrity Consultant at QbD Group, Pieter Smits, Project Manager at QbD Group
  Leveraging AI in life sciences is powerful, but also complex under GxP. In this joint webinar, QbD Group and delaware show how to implement AI in a trustworthy, validated, and inspection-ready way, with the right approach to data, explainab
- [From Strategy to First-in-Human: A Practical Roadmap for Biotech Development](https://qbdgroup.com/en/webinars/from-strategy-to-first-in-human) — 2026-03-18 · Pharma & Biotech · QbD Group
  Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, C
- [Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space](https://qbdgroup.com/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space) — 2026-03-17 · Regulatory Affairs
  Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD m
- [Cleaning Validation Based on PDEs](https://qbdgroup.com/en/webinars/cleaning-validation-based-on-pdes-on-demand) — 2026-03-13 · Qualification & Validation
  Join our webinar and discover how to apply PDEs (Permitted Daily Exposures) to minimize critical risks and ensure regulatory compliance, combining science, statistics, and advanced digital tools. Learn from experts how to transform cleaning
- [Getting Started: Overcoming Initial Obstacles in Medical Device Software Development](https://qbdgroup.com/en/webinars/webinar-on-demand-getting-started-overcoming-initial-obstacles-in-medical-device-software-development) — 2026-03-07 · Medical Devices
  Ever wondered what it really takes for manufacturers to break into the Medical Devices market? This webinar covers major challenges in software qualification and classification for different functionalities.
- [Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges](https://qbdgroup.com/en/webinars/webinar-on-demand-extractables-leachables-in-pharma) — 2026-03-07 · Pharma
  This webinar on demand aims to provide a comprehensive overview of Extractables and Leachables (E&L) in pharmaceutical products, highlighting regulatory complexities, toxicological challenges, and practical approaches to study design and ri
- [Drug-Device Combination Products & Article 117](https://qbdgroup.com/en/webinars/webinar-on-demand-drug-device-combination-products-and-article-117) — 2026-03-07 · Pharma
  Are the regulatory complexities of Drug-Device Combination Products overwhelming you? This webinar explores the latest advancements and insights regarding integral Combination Products that must be registered as drugs under the current legi
- [Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs](https://qbdgroup.com/en/webinars/webinar-on-demand-scaling-pharmacovigilance-in-europe) — 2026-03-07 · Pharma & Biotech
  Watch our webinar on demand and learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies.
- [From Requirements to Code: a unified MDSW development cycle that covers all requirements](https://qbdgroup.com/en/webinars/webinar-on-demand-from-requirements-to-code-streamlining-your-medical-device-software-development-cycle) — 2026-03-07 · Medical Devices
  This webinar explores the specific requirements for various safety classifications and provides valuable insights into what Notified Bodies (NBs) and the FDA expect from your development process.
- [Website storytelling: turning science into engagement](https://qbdgroup.com/en/webinars/webinar-on-demand-website-storytelling) — 2026-03-07 · Medical Devices, IVD & Pharma
  Watch an exclusive webinar where we reveal how to transform technical information into a compelling website that connects with your audience.
- [Unlock the strategic value of PMS and PMCF under EU MDR](https://qbdgroup.com/en/webinars/webinar-on-demand-pms-pmcf-compliance-for-medical-devices-under-eu-mdr) — 2026-03-07 · Medical Devices
  Far beyond a compliance checkbox, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) are essential drivers of product safety, clinical validation, and long-term market success.
- [Cleaning Validation Based on PDEs](https://qbdgroup.com/en/webinars/cleaning-validation-based-on-pdes) — 2026-03-07 · Qualification & Validation
  Join our webinar and discover how to apply PDEs (Permitted Daily Exposures) to minimize critical risks and ensure regulatory compliance, combining science, statistics, and advanced digital tools. Learn from experts how to transform cleaning
- [Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations](https://qbdgroup.com/en/webinars/webinar-on-demand-nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations) — 2026-03-04 · Pharma · QbD Group
  Nitrosamine impurities continue to challenge pharmaceutical companies. This webinar will help you understand the regulatory framework, perform effective risk analysis using a clear, science-based, and practical approach.
- [Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations](https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations) — 2026-03-04 · Pharma · QbD Group
  Manage the risk of nitrosamines in the pharmaceutical industry. Watch our webinar on demand and learn about regulation and risk analysis from experts.
- [Entering the European MedTech Market: Why One Approval Doesn't Fit All](https://qbdgroup.com/en/webinars/entering-the-european-medtech-market-why-one-approval-doesnt-fit-all) — 2026-03-03 · Medical Devices
  This webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, N
- [From R&D to market: IP and regulatory strategy across the product life cycle](https://qbdgroup.com/en/webinars/webinar-on-demand-from-rd-to-market-ip-and-regulatory-strategy) — 2026-02-26 · Life Sciences · QbD Group
  Watch this Biovia x Gevers x QbD Group webinar on demand to explore product life cycle strategies, focusing on R&D, regulatory alignment, and Quality by Design insights for life sciences professionals.
- [From R&D to market: IP and regulatory strategy across the product life cycle](https://qbdgroup.com/en/webinars/from-rd-to-market-ip-and-regulatory-strategy) — 2026-02-26 · Life Sciences · QbD Group
  This webinar follows the stages of a product’s life cycle, explaining how structured, science-based development and intellectual property considerations support regulatory alignment and long-term value creation.
- [Fast GxP Compliance](https://qbdgroup.com/en/webinars/fast-gxp-compliance) — 2026-01-21 · Life Sciences · QbD Group
  Life sciences companies must digitalize fast while staying GxP compliant. In this joint webinar, QbD Group and delaware show how SAP technology and proven validation frameworks make rapid, compliant digital transformation possible. Particip
- [Fast GxP Compliance: Implementing and Validating ERP Systems Under GxP](https://qbdgroup.com/en/webinars/webinar-on-demand-fast-gxp-compliance) — 2026-01-21 · Life Sciences · QbD Group
  Life sciences companies must digitalize fast while staying GxP compliant. In this joint webinar, QbD Group and delaware show how SAP technology and proven validation frameworks make rapid, compliant digital transformation possible.
- [Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs](https://qbdgroup.com/en/webinars/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs) — 2025-11-13 · Pharma · QbD Group
  This webinar provides guidance on managing pharmacovigilance (PV) across Europe, focusing on balancing global consistency with country-specific requirements. Participants will learn to meet strict European timelines while working with lean 
- [Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety](https://qbdgroup.com/en/webinars/webinar-on-demand-pharmacovigilance-and-risk-management-in-innovative-therapies) — 2025-05-15 · Pharma & Biotech · QbD Group
  The webinar discusses the evolving pharmacovigilance and risk management environment of innovative therapies, emphasizing safety challenges in cell, CAR T, and RNA-based treatments, as well as gaps in regulation and surveillance strategies.
- [Pharmacovigilance and Risk Management in Innovative Therapies](https://qbdgroup.com/en/webinars/pharmacovigilance-and-risk-management-in-innovative-therapies) — 2025-05-15 · Pharma & Biotech · QbD Group
  The webinar discusses the evolving pharmacovigilance and risk management environment of innovative therapies, emphasizing safety challenges in cell, CAR T, and RNA-based treatments, as well as gaps in regulation and surveillance strategies.
- [Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges](https://qbdgroup.com/en/webinars/extractables-leachables-in-pharma-navigating-evolving-regulations-and-toxicological-challenges) — 2025-05-13 · Pharma · QbD Group
  This webinar offers a foundational understanding of Extractables and Leachables (E&L), highlighting their impact on drug safety and stability, and current regulatory frameworks. It covers toxicological assessments and best practices in stud
- [From Strategy to First-in-Human: A Practical Roadmap for Biotech Development](https://qbdgroup.com/en/webinars/from-strategy-to-first-in-human-on-demand) — 2025-03-18 · Pharma & Biotech
  Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, C
- [Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation](https://qbdgroup.com/en/webinars/webinar-on-demand-mdsw-clinical-evidence) — 2025-01-09 · Medical Devices · QbD Group
  Join our webinar to explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices.
- [Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation](https://qbdgroup.com/en/webinars/mdsw-clinical-evidence) — 2025-01-09 · Medical Devices · QbD Group
  Join our webinar to explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices. We’ll discuss the critical role of clinical validation star
- [From Requirements to Code: a unified MDSW development cycle that covers all requirements](https://qbdgroup.com/en/webinars/mdsw-design-development) — 2025-01-06 · Medical Devices · QbD Group
  This webinar will explore the specific requirements for various safety classifications and provide valuable insights into what Notified Bodies (NBs) and the FDA expect from your development process. Key topics will include the full developm
- [From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software](https://qbdgroup.com/en/webinars/mdsw-market-access) — 2024-12-24 · Medical Devices · QbD Group
  This webinar will guide you through the essential steps of market access, effective commercialization strategies, and all the critical factors needed for a successful MDSW product launch. Whether you’re a seasoned professional or new to the
- [From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software](https://qbdgroup.com/en/webinars/webinar-on-demand-mdsw-market-access) — 2024-12-24 · Medical Devices · QbD Group
  Learn how to launch your Medical Device Software successfully with expert insights on market access and commercialization strategies.
- [Drug-Device Combination Products and Article 117](https://qbdgroup.com/en/webinars/drug-device-combination-products-article-117) — 2024-12-17 · Combination Products · QbD Group
  Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.
- [Unlocking Strategic Value in Drug Safety for Life Sciences Organizations](https://qbdgroup.com/en/webinars/webinar-on-demand-unlocking-strategic-value-in-safety-for-life-sciences-organizations) — 2024-12-08 · Pharma · QbD Group
  This webinar aims to explore the transformation of safety teams from reactive cost centers to proactive benefit drivers, emphasizing the importance of providing teams with the right tools & resources to gain actionable insights.
- [Unlocking Strategic Value in Drug Safety for Life Sciences Organizations](https://qbdgroup.com/en/webinars/unlocking-strategic-value-in-safety-for-life-sciences-organizations) — 2024-12-08 · Pharma · QbD Group
  This webinar aims to explore the transformation of safety teams from reactive cost centers to proactive benefit drivers, emphasizing the importance of providing teams with the right tools & resources to gain actionable insights.
- [From Paper to Practice: Technical Documentation Essentials for Medical Device Software](https://qbdgroup.com/en/webinars/webinar-on-demand-mdsw-technical-documentation) — 2024-11-20 · Medical Devices · QbD Group
  Watch our webinar to gain practical insights on crafting essential technical documentation (TD) with confidence.
- [From Paper to Practice: Technical Documentation Essentials for Medical Device Software](https://qbdgroup.com/en/webinars/mdsw-technical-documentation) — 2024-11-20 · Medical Devices · QbD Group
  Watch our webinar to gain practical insights on crafting essential technical documentation (TD) with confidence. We’ll take you step-by-step through interpreting MDR requirements, choosing the right accredited Notified Body, and navigating 
- [Getting Started: Overcoming Initial Obstacles in Medical Device Software Development](https://qbdgroup.com/en/webinars/mdsw-obstacles) — 2024-11-19 · Medical Devices · QbD Group
  Watch our webinar where we address major challenges in software qualification and classification for different functionalities. We explore MDR for software-hardware combinations and how AI is handled under the AI Act. In addition, we share 
- [How to manage mandatory communication of Toxicological Risks?](https://qbdgroup.com/en/webinars/how-to-manage-mandatory-communication-of-toxicological-risks) — 2024-11-19 · Toxicology · QbD Group
  This webinar provides invaluable information on how to address and manage toxicological risks in the pharmaceutical industry, emphasizing the importance of timely and transparent communication. The session will cover essential strategies fo
- [How to manage mandatory communication of Toxicological Risks?](https://qbdgroup.com/en/webinars/webinar-on-demand-how-to-manage-mandatory-communication-of-toxicological-risks) — 2024-11-19 · Toxicology · QbD Group
  This webinar provides invaluable information on how to address and manage toxicological risks in the pharmaceutical industry, emphasizing the importance of timely and transparent communication. The session will cover essential strategies fo
- [Mastering Clinical Performance Studies under IVDR](https://qbdgroup.com/en/webinars/mastering-clinical-performance-studies-under-ivdr-from-strategy-to-delivery) — 2024-11-12 · In Vitro Diagnostics · QbD Group
  Learn how to design and deliver successful clinical performance studies under IVDR. Explore strategic, regulatory, and operational aspects with expert guidance.
- [Mastering Clinical Performance Studies under IVDR](https://qbdgroup.com/en/webinars/webinar-on-demand-mastering-clinical-performance-studies-under-ivdr-from-strategy-to-delivery) — 2024-11-12
  Learn how to design and deliver successful clinical performance studies under IVDR. Explore strategic, regulatory, and operational aspects with expert guidance.
- [Setting up ATMP Quality Management Systems: Strategies for Compliance and Success](https://qbdgroup.com/en/webinars/webinar-on-demand-atmp-quality-management-systems-strategies-for-compliance-and-success) — 2024-11-12 · Pharma & Biotech · QbD Group
  During this webinar you will learn how to effectively prepare for a compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.
- [Setting up ATMP Quality Management Systems: Strategies for Compliance and Success](https://qbdgroup.com/en/webinars/atmp-quality-management-systems-strategies-for-compliance-and-success) — 2024-11-12 · Pharma & Biotech · QbD Group
  During this webinar you will learn how to effectively prepare for a compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.
- [ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy](https://qbdgroup.com/en/webinars/webinar-on-demand-atmp-supply-chain-navigating-the-challenges-and-exploring-the-vein-to-vein-strategy) — 2024-11-11 · Pharma & Biotech · QbD Group
  In this webinar we dive into the fascinating world of the ATMP (Advanced Therapy Medicinal Products) supply chain. Discover how to overcome the main challenges faced by industry leaders and gain fascinating insights into the innovative vein
- [Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems](https://qbdgroup.com/en/webinars/second-edition-of-gamp-5-a-risk-based-approach-to-compliant-gxp-computerized-systems) — 2024-10-14 · Medical Devices · QbD Group
  This webinar will tell you more about the second edition of GAMP 5, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5: Records and Data Integrity Guide, recognition of the FDA’s current work on computer sof
- [Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems](https://qbdgroup.com/en/webinars/webinar-on-demand-second-edition-of-gamp-5-a-risk-based-approach-to-compliant-gxp-computerized-systems) — 2024-10-14
  This webinar will tell you more about the second edition of GAMP 5, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5: Records and Data Integrity Guide, recognition of the FDA’s current work on computer sof
- [3D Printing in the Healthcare World](https://qbdgroup.com/en/webinars/3d-printing-in-the-healthcare-world-challenges-opportunities-regulations) — 2024-09-17 · Medical Devices · QbD Group
  The webinar provides an exclusive insight into healthcare manufacturing 3D printing. Learn from the direct expertise of Michaël Vandezande, Stijn Paridaens and Anne-Sophie Grell. With their vast knowledge in prototyping as well as in mass-m
- [3D Printing in the Healthcare World](https://qbdgroup.com/en/webinars/webinar-on-demand-3d-printing-in-the-healthcare-world-challenges-opportunities-regulations) — 2024-09-17
  The webinar provides an exclusive insight into healthcare manufacturing 3D printing. Learn from the direct expertise of Michaël Vandezande, Stijn Paridaens and Anne-Sophie Grell. With their vast knowledge in prototyping as well as in mass-m
- [IVDR Extension Explained: Tips & Strategies](https://qbdgroup.com/en/webinars/ivdr-extension-explained-tips-strategies) — 2024-09-11 · In Vitro Diagnostics · QbD Group
  The journey towards adopting the IVD regulations introduced in 2017 has been ongoing for some time, presenting challenges for many in the industry. This session will provide you with the latest updates on the IVDR extension and its impact o
- [IVDR Extension Explained: Tips & Strategies](https://qbdgroup.com/en/webinars/webinar-on-demand-ivdr-extension-explained-tips-strategies) — 2024-09-11 · In Vitro Diagnostics · QbD Group
  Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.
- [PMS & PMCF Webinar Series – EU MDR Compliance Tips](https://qbdgroup.com/en/webinars/pms-pmcf) — 2023-10-01 · Medical Devices · QbD Group
  Watch our two on-demand webinars and discover how to turn PMS & PMCF compliance into clinical and strategic advantage — with exclusive insights from a notified body.
- [Website storytelling: turning science into engagement](https://qbdgroup.com/en/webinars/website-storytelling-turning-science-into-engagement) — 2023-10-01 · Medical Devices · QbD Group
  In this webinar on demand, we’ll reveal how to transform technical information into a compelling website that connects with your audience. This session will address critical questions that impact your organization’s reach and reputation. Yo
- [Post-Market Surveillance Requirements for Medical Devices and IVDs](https://qbdgroup.com/en/webinars/webinar-on-demand-post-market-surveillance-requirements-for-medical-devices-and-ivds) — 2023-09-25 · Medical Devices · QbD Group
  This webinar on demand will explain how PMS includes all the activities carried out by the manufacturer to monitor, measure, and assess the device’s quality, performance and safety to ensure that the benefit-risk profile of the device remai
- [Post-Market Surveillance Requirements for Medical Devices and IVDs](https://qbdgroup.com/en/webinars/post-market-surveillance-requirements-for-medical-devices-and-ivds) — 2023-09-25 · Medical Devices · QbD Group
  This webinar on demand will explain how PMS includes all the activities carried out by the manufacturer to monitor, measure, and assess the device’s quality, performance and safety to ensure that the benefit-risk profile of the device remai
- [The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body](https://qbdgroup.com/en/webinars/the-medical-device-ce-certification-pathway-explained) — 2023-07-12 · Regulatory Affairs · QbD Group
  In this webinar on demand, we will provide a concise explanation of the process involved in qualifying and classifying a medical device. We will also discuss the most suitable method of conformity assessment to follow and shed light on how 
- [The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body](https://qbdgroup.com/en/webinars/webinar-on-demand-the-medical-device-ce-certification-pathway-explained) — 2023-07-12 · Regulatory Affairs · QbD Group
  Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body.

## Company News

- [Rescop's e-VLM validation software rebrands as VLMcare](https://qbdgroup.com/en/news/rescops-e-vlm-rebrands-as-vlmcare) — 2026-07-01 · Company News · QbD Group
  Rescop, a QbD Group company, today announces the rebrand of its established e-VLM software to VLMcare — a data-driven, AI-enhanced platform for validation lifecycle management in GxP-regulated life sciences environments.
- [QbD Group awarded Platinum label as Best Managed Company 2026](https://qbdgroup.com/en/news/qbd-group-awarded-platinum-label-as-best-managed-company-2026) — 2026-05-29 · Award · QbD Group
  QbD Group awarded Platinum label as Best Managed Company 2026, marking seven consecutive years of recognition for excellence in the life sciences industry.
- [QbD Group and Vigintake Partner to Drive the Digital Transformation of Pharmacovigilance](https://qbdgroup.com/en/news/qbd-group-vigintake-partner-digital-transformation-safety-processes) — 2026-05-13 · Partnerships · QbD Group
  At QbD Group, we are joining forces with Vigintake to support the evolution of pharmacovigilance operations through intelligent automation and innovative digital solutions, combining regulatory expertise, quality systems, and advanced techn
- [QbD Group acquires Rescop, expanding its Software Solutions & Services division and strengthening its presence in the Netherlands, Poland, G](https://qbdgroup.com/en/news/qbd-group-acquires-rescop-expanding-software-solutions-services-division) — 2026-05-12 · Acquisition · QbD Group
  QbD Group today announces the acquisition of Rescop, a specialist in GxP compliance, computer system validation, and validation software for the life sciences industry.
- [QbD Group wins AEFI Award for Best Publication of 2025 for its article on pharmacovigilance in innovative therapies](https://qbdgroup.com/en/news/qbd-group-wins-aefi-award-best-publication-2025) — 2026-05-05 · Award · QbD Group
  QbD Group has been recognized with the AEFI Award for Best Publication of 2025 for the article "Pharmacovigilance in innovative therapies: Regulatory and clinical challenges," authored by Almudena del Castillo, Head of Global Vigilance Divi
- [QbD Group and delaware strengthen partnership to accelerate digitalization in life sciences](https://qbdgroup.com/en/news/qbd-group-and-delaware-strengthen-partnership) — 2025-11-27 · Partnership · QbD Group
  QbD Group & delaware announce a new partnership to help life sciences companies accelerate their digital transformation while ensuring full GxP compliance.
- [QbD Group Joins ASEBIO: A strategic Step in Our Commitment to Scientific Excellence](https://qbdgroup.com/en/news/qbd-group-joins-asebio) — 2025-11-12 · Company · QbD Group
  QbD Group joins ASEBIO, strengthening its commitment to quality, compliance, and safety within the Spanish life sciences sector.
- [QbD Group recognized as Best Pharmacovigilance Service Company at Farmaforum 2025](https://qbdgroup.com/en/news/qbd-group-recognized-as-best-pharmacovigilance-service-company-at-farmaforum-2025) — 2025-09-19 · Award · QbD Group
  QbD Group has been awarded the title of Best Pharmacovigilance Service Company at the latest edition of Farmaforum.
- [QbD Group welcomes Dr. Diane Fairweather as Division Head Clinical](https://qbdgroup.com/en/news/qbd-group-welcomes-diane-fairweather-as-division-head-clinical) — 2025-05-27 · People · QbD Group
  QbD Group welcomes Dr. Diane Fairweather as Division Head Clinical, with 25+ years in global clinical leadership to strengthen and scale the division.
- [QbD Group awarded Gold Label as Best Managed Company 2025](https://qbdgroup.com/en/news/qbd-group-awarded-gold-label-as-best-managed-company-2025) — 2025-05-23 · Award · QbD Group
  QbD Group awarded Gold Label as Best Managed Company 2025, marking six consecutive years of recognition for excellence in the life sciences industry.
- [Dr. Angeles Escarti-Nebot joins QbD Group as Division Head Regulatory Affairs](https://qbdgroup.com/en/news/dr-angeles-escarti-nebot-joins-qbd-group-as-division-head-regulatory-affairs) — 2025-05-06 · People · QbD Group
  Dr. Angeles Escarti-Nebot joins QbD Group as Head of Regulatory Affairs, bringing global regulatory expertise to advance innovation in life sciences.
- [Azierta fully integrated into QbD Group](https://qbdgroup.com/en/news/azierta-fully-integrated-into-qbd-group) — 2025-02-10 · Acquisition · QbD Group
  Azierta integrates into QbD Group, expanding services and global reach, enhancing client value and employee opportunities in life sciences consultancy.
- [QbD Group unveils evolved brand identity, reflecting strategic evolution and vision for the future](https://qbdgroup.com/en/news/qbd-group-unveils-new-brand-identity) — 2025-02-10 · Company · QbD Group
  QbD Group unveils a new brand identity to reflect its growth, expanded services, and commitment to innovation in the life sciences sector.
- [QbD Group strengthens global leadership with the appointment of Almudena del Castillo as Division Head of Vigilance & Country Manager for Sp](https://qbdgroup.com/en/news/qbd-group-strengthens-global-leadership-with-the-appointment-of-almudena-del-castillo-as-division-head-of-vigilance-country-manager-for-spain) — 2025-02-03 · People · QbD Group
  Almudena del Castillo joins QbD Group as Division Head of Vigilance and Country Manager for Spain, strengthening leadership and patient safety.
- [QbD Group announces acquisition of SciencePharma, strengthening global regulatory and quality expertise](https://qbdgroup.com/en/news/qbd-group-announces-acquisition-of-sciencepharma-strengthening-global-regulatory-and-quality-expertise) — 2024-12-04 · Acquisition · QbD Group
  QbD Group and SciencePharma have reached an agreement for QbD Group to acquire SciencePharma.
- [Annual Update event on the QbD Research Chair for Precision Oncology Research in Glioblastoma](https://qbdgroup.com/en/news/annual-update-event-on-the-qbd-research-chair-for-precision-oncology-research-in-glioblastoma) — 2024-06-21 · Foundation · QbD Group
  Annual update on the QbD Research Chair for Precision Oncology in glioblastoma, highlighting patient-centered care, research progress, and a tribute.
- [QbD Group Once Again Awarded Gold Label as Best Managed Company](https://qbdgroup.com/en/news/qbd-group-once-again-awarded-gold-label-as-best-managed-company) — 2024-05-31 · Award · QbD Group
  QbD Group earns its fifth consecutive Gold label as Best Managed Company, recognized for its exceptional strategy, competencies, and financial results.
- [Timeseer.AI and QbD Group Forge Strategic Partnership to Enhance Sensor Data Quality in Life Sciences](https://qbdgroup.com/en/news/timeseerai-and-qbd-group-forge-strategic-partnership-to-enhance-sensor-data-quality-in-life-sciences) — 2024-02-19 · Partnership · QbD Group
  Timeseer.AI and QbD Group enhance sensor data quality in life sciences, ensuring reliable information and better patient care.
- [QbD Chair in Precision Oncology Research for Glioblastoma Renewed for Three More Years](https://qbdgroup.com/en/news/qbd-chair-in-precision-oncology-research-for-glioblastoma-renewed-for-three-more-years) — 2024-01-17 · Foundation · QbD Group
  QbD Chair in Precision Oncology for Glioblastoma is extended three years, honoring a personal story and advancing innovative cancer treatments.
- [Salma Michor assumes role as Regulatory Affairs Division Head at the QbD Group](https://qbdgroup.com/en/news/salma-michor-appointed-as-head-of-regulatory-affairs-division-at-qbd-group) — 2024-01-09 · People · QbD Group
  Salma Michor joins QbD Group as Head of Regulatory Affairs, bringing extensive expertise and leadership to strengthen the regulatory team.
- [Bart Van Acker Establishes Chair to Combat Glioblastoma in Honor of Close Friend's Battle with Aggressive Brain Tumor](https://qbdgroup.com/en/news/bart-van-acker-establishes-chair-to-combat-glioblastoma-in-honor-of-close-friends-battle-with-aggressive-brain-tumor) — 2023-11-27 · Foundation · QbD Group
  Bart Van Acker honors a friend's memory by funding research on glioblastoma, aiming to accelerate treatment development through a new chair at Leuven University.
- [QbD Group's Salma Michor Honored as 2023 RAPS Fellow](https://qbdgroup.com/en/news/qbd-groups-salma-michor-honored-as-2023-raps-fellow) — 2023-10-30 · Award · QbD Group
  Salma Michor honored as a 2023 RAPS Fellow for her exceptional leadership and contributions to the regulatory profession.
- [QbD Group Acquires Life Sciences Consultancy Azierta to Strengthen Global Vigilance Services and Broaden Presence in Spain](https://qbdgroup.com/en/news/qbd-group-acquires-life-sciences-consultancy-azierta-to-strengthen-global-vigilance-services-and-broaden-presence-in-spain) — 2023-09-05 · Acquisition · QbD Group
  QbD Group acquires Azierta to strengthen global vigilance services and expand its presence in Spain.
- [Belgians Launch Miniature Heart into Space for Groundbreaking Aging Research](https://qbdgroup.com/en/news/belgians-launch-miniature-heart-into-space-for-groundbreaking-aging-research) — 2023-08-30 · Innovation · QbD Group
  Belgian researchers launch a 3D bioprinted miniature heart to the ISS to advance understanding of heart aging and improve cardiovascular health.
- [QbD Group Acquires Michor Consulting to Strengthen Regulatory Affairs Expertise Across Europe](https://qbdgroup.com/en/news/qbd-group-acquires-michor-consulting-to-strengthen-regulatory-affairs-expertise-across-europe) — 2023-05-25 · Acquisition · QbD Group
  QbD Group acquires Michor Consulting to enhance regulatory affairs expertise and expand services in Europe, particularly in the DACH region.
- [QbD Group awarded Deloitte's Best Managed Company Gold Label](https://qbdgroup.com/en/news/qbd-group-awarded-deloittes-best-managed-company-gold-label) — 2023-05-12 · Award · QbD Group
  QbD Group receives its fourth consecutive Best Managed Companies label and the Gold Label from Deloitte.
- [QbD Group Foundation: Strengthening Our Commitment to Social Impact](https://qbdgroup.com/en/news/qbd-group-foundation-strengthening-our-commitment-to-social-impact) — 2023-03-30 · Foundation · QbD Group
  Learn how the QbD Group Foundation strengthens social impact through science, healthcare, environmental initiatives, and local community engagement.
- [QbD Group Acquires EUDRAC Ltd., Expanding Regulatory Affairs and Pharmacovigilance Services for Pharmaceutical Clients](https://qbdgroup.com/en/news/qbd-group-acquires-eudrac-ltd-expanding-regulatory-affairs-and-pharmacovigilance-services-for-pharmaceutical-clients) — 2022-11-08 · Acquisition · QbD Group
  QbD Group acquires EUDRAC Ltd., expanding regulatory affairs and pharmacovigilance services.
- [Qarad's eIFU Services Rebrand as 'IFUcare'](https://qbdgroup.com/en/news/qarads-eifu-services-rebrand-as-ifucare) — 2022-10-19 · Company · QbD Group
  Qarad rebrands its eIFU services as IFUcare, enhancing visibility and compliance for distributing medical device instructions digitally.
- [Quality by Design and TRIUM Forge a Strategic Alliance](https://qbdgroup.com/en/news/quality-by-design-and-trium-forge-a-strategic-alliance) — 2022-05-09 · Partnership · QbD Group
  Quality by Design and TRIUM form a strategic alliance to offer comprehensive end-to-end solutions for the life cycle of medical products and therapies.
- [Rebranding Announcement: TRIUM Clinical Consulting is Now QbD Clinical](https://qbdgroup.com/en/news/rebranding-announcement-trium-clinical-consulting-is-now-qbd-clinical) — 2022-05-09 · Company · QbD Group
  TRIUM Clinical Consulting has rebranded to QbD Clinical, expanding its service offerings within the QbD Group.
- [QbD Wallonia Expands: Welcoming a New Office and a Strengthened Team](https://qbdgroup.com/en/news/qbd-wallonia-expands-welcoming-a-new-office-and-a-strengthened-team) — 2022-02-09 · Company · QbD Group
  QbD Wallonia expands with a new office in Gosselies, focusing on biotech and ATMP, and strengthens its team to drive growth.
- [Quality by Design Grows Stronger: A Warm Welcome to Qarad!](https://qbdgroup.com/en/news/quality-by-design-grows-stronger-a-warm-welcome-to-qarad) — 2021-09-02 · Acquisition · QbD Group
  Quality by Design expands its services by welcoming Qarad, enhancing its expertise in Regulatory Affairs and Quality Assurance for IVD.
- [Introducing Scilife: QbD Software's Major Rebranding Initiative](https://qbdgroup.com/en/news/introducing-scilife-qbd-softwares-major-rebranding-initiative) — 2021-06-07 · Company · QbD Group
  Discover Scilife: QbD Software's rebrand to enhance value, user-friendliness, and industry leadership in Life Sciences.
- [New Partnership: QUERCUS Labo (QC) Joins QbD Group](https://qbdgroup.com/en/news/new-partnership-quercus-labo-qc-joins-qbd-group) — 2021-01-18 · Partnership · QbD Group
  QUERCUS Labo joins QbD Group, strengthening quality control services and expertise in life sciences.

## Events

- [World Patient Safety Congress Europe](https://qbdgroup.com/en/events/world-patient-safety-congress-europe-2026) — 2026-08-07
  Meet QbD Group at booth 407 during World Patient Safety Congress Europe 2026, 22-24 September at RAI Amsterdam, The Netherlands.
- [MEDICA 2026](https://qbdgroup.com/en/events/medica-2026) — 2026-07-22 · Medical Devices · QbD Group
  Meet QbD Group at booth 3D34 during MEDICA 2026, the world's leading trade fair for medical technology and healthcare, 16-19 November at Düsseldorf, Germany.
- [CPHI Milan 2026](https://qbdgroup.com/en/events/cphi-milan-2026) — 2026-07-02 · Pharma & Biotech · QbD Group
  Meet QbD Group at booth 12P54 during CPHI Milan 2026, the world's largest pharmaceutical event, 6-8 October at Fiera Milano.
- [Farmaforum 2026](https://qbdgroup.com/en/events/farmaforum-2026) — 2026-07-01 · Pharma & Biotech
  Meet QbD Group at Farmaforum 2026 in Madrid — booth H08 and two expert workshops on Pharma 4.0, AI-powered manufacturing and FDA inspection readiness under Annex 1.
- [Symposium AEFI 2026](https://qbdgroup.com/en/events/symposium-aefi-2026) — 2026-04-16 · Quality Assurance
  Join QbD Group at the 43rd AEFI Symposium in Barcelona — a special edition celebrating the association's 50th anniversary, bringing together pharmaceutical professionals around lectures, roundtables and workshops.
- [2nd Annual Outsourcing in Clinical Trials: Medical Devices USA 2026](https://qbdgroup.com/en/events/outsourcing-clinical-trials-medical-devices-usa-2026) — 2026-04-02 · Medical Devices
  The 2nd Annual Outsourcing in Clinical Trials: Medical Devices USA brings together clinical, regulatory, and commercial leaders from the medical device and diagnostics community.
- [Knowledge for Growth 2026](https://qbdgroup.com/en/events/knowledge-for-growth-2026) — 2026-04-02 · Pharma & Biotech
  Join industry leaders at Knowledge for Growth 2026 in Antwerp to explore life sciences innovations, trends, and networking opportunities that shape the future of biotech and pharma.
- [RAPS Euro Convergence 2026](https://qbdgroup.com/en/events/raps-euro-convergence-2026) — 2026-03-04 · Regulatory Affairs
  Join industry leaders at RAPS Convergence 2026 in Lisbon to network with experts, and enhance your understanding of regulatory affairs.
- [ADLM 2026](https://qbdgroup.com/en/events/adlm-2026) — 2026-02-19 · In Vitro Diagnostics
  ADLM 2026 (formerly AACC) — Where Great Minds Meet. The global event for clinical chemistry, molecular diagnostics, mass spectrometry, and laboratory medicine with 750+ exhibitors and 250+ educational sessions.
- [VIB Knowledge Session](https://qbdgroup.com/en/events/vib-knowledge-session-2026) — 2026-02-19 · Medical Devices
  VIB Knowledge Session bringing together life sciences researchers, biotech professionals, and industry leaders in Ghent for knowledge exchange and networking.
- [Expopharm 2026](https://qbdgroup.com/en/events/expopharm-2026) — 2026-02-19 · Pharma & Biotech
  Europe's leading pharmaceutical trade fair for pharmacies, connecting exhibitors with pharmacy professionals. Featuring innovations, workshops, and extensive networking opportunities in Munich.
- [World Drug Safety Congress Europe 2026](https://qbdgroup.com/en/events/world-drug-safety-congress-europe-2026) — 2026-02-19 · Pharma & Biotech
  Leading European congress dedicated to drug safety, pharmacovigilance, and risk management, gathering industry professionals to discuss the latest developments in patient safety and regulatory compliance.
- [Eurobiotech 2026 – 10th Central European Congress of Life Sciences](https://qbdgroup.com/en/events/eurobiotech-2026) — 2026-02-19 · Pharma & Biotech
  The 10th Central European Congress of Life Sciences EUROBIOTECH, a premier event in Krakow bringing together scientists, biotech companies, and industry leaders to discuss the latest advances in life sciences.
- [40th Pharmacovigilance UK & EU 2026](https://qbdgroup.com/en/events/pharmacovigilance-uk-eu-2026) — 2026-02-19 · Pharma & Biotech
  The 15th Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials. Themed "AI, Access, and Accountability: Shaping the Next Era of Pharmacovigilance & Drug Safety".
- [PCI Days 2026](https://qbdgroup.com/en/events/pci-days-2026) — 2026-02-19 · Pharma & Biotech
  The largest B2B trade fair in Central and Eastern Europe for the pharmaceutical, cosmetics, and dietary supplements industries. Three days of business meetings, supplier showcases, and innovation presentations.
- [TOPRA Symposium 2026](https://qbdgroup.com/en/events/topra-symposium-2026) — 2026-02-19 · Pharma & Biotech
  The TOPRA Annual Symposium is the premier event for regulatory affairs professionals, offering expert sessions, networking, and the latest regulatory developments. Held over three days in Utrecht.
- [Digital Transformation & AI in Pharma 2026](https://qbdgroup.com/en/events/digital-transformation-ai-pharma-2026) — 2026-02-19 · Pharma & Biotech
  Conference on digital transformation and artificial intelligence in the pharmaceutical industry, covering GxP-relevant AI topics, Industry 4.0, and practical case studies from pharma companies.
- [Biospain 2026](https://qbdgroup.com/en/events/biospain-2026) — 2026-02-19 · Pharma & Biotech
  Spain's leading biotech partnering and networking event, bringing together biotech companies, pharma, investors, and researchers. Organized by AseBio, it is the largest biotech conference in Southern Europe.
- [Ogólnopolska Konferencja PACTT](https://qbdgroup.com/en/events/pactt-2026) — 2026-02-19 · Pharma & Biotech
  The Polish National PACTT Conference focusing on technology transfer, knowledge exchange and innovation in the academic and scientific community.
- [HealthTechInvestor Summit 2026](https://qbdgroup.com/en/events/healthtechinvestor-summit-2026) — 2026-02-19 · Medical Devices
  The HealthTechInvestor Summit connects health technology companies with investors, venture capitalists, and industry stakeholders. A premier event for health tech innovation and investment in Europe.
- [Dutch Life Sciences Conference 2026](https://qbdgroup.com/en/events/dutch-life-sciences-conference-2026) — 2026-02-19 · Medical Devices
  The premier Dutch Life Sciences conference bringing together industry leaders, startups, investors, and researchers to discuss innovation and trends in the life sciences sector.
- [PIPA Conference 2026](https://qbdgroup.com/en/events/pipa-conference-2026) — 2026-02-19 · Pharma & Biotech
  The PIPA Conference dedicates one day to pharmacovigilance and one day to medical information, providing focused agendas and networking opportunities. Held at Denham Grove Hotel.
- [ESMO Congress 2026](https://qbdgroup.com/en/events/esmo-congress-2026) — 2026-02-19 · Pharma & Biotech
  The European Society for Medical Oncology Congress — Europe's leading oncology event, featuring cutting-edge clinical research, educational sessions, and networking for oncology professionals worldwide.
- [World CB & CDx Summit Europe](https://qbdgroup.com/en/events/world-cb-cdx-summit-europe-2026) — 2026-02-17 · In Vitro Diagnostics
  World Companion Biomarker & CDx Summit in London.
- [BioEurope Spring](https://qbdgroup.com/en/events/bioeurope-spring-2026) — 2026-02-17 · Pharma & Biotech
  BioEurope Spring partnering event in Lisbon.
- [ESCMID Global 2026](https://qbdgroup.com/en/events/escmid-global-2026) — 2026-02-17 · In Vitro Diagnostics
  ESCMID Global congress in Munich.
- [Pharmacy Expo Poland 2026](https://qbdgroup.com/en/events/pharmacy-expo-poland-2026) — 2026-02-17 · Pharma & Biotech
  Pharmacy expo in Warsaw covering pharma, devices and IVD.
- [DIA Europe 2026 Annual Meeting](https://qbdgroup.com/en/events/dia-europe-2026) — 2026-02-17 · Pharma & Biotech
  DIA Europe annual meeting in Rotterdam.
- [CACLP](https://qbdgroup.com/en/events/caclp-2026) — 2026-02-17 · In Vitro Diagnostics
  CACLP conference in Fujian, China.
- [ISPE Annual Conference 2026](https://qbdgroup.com/en/events/ispe-annual-conference-2026) — 2026-02-17 · Pharma & Biotech
  ISPE Europe annual conference in Copenhagen.
- [Medicalforum 2026](https://qbdgroup.com/en/events/medicalforum-2026) — 2026-02-17 · Medical Devices
  Medical devices forum in Barcelona.
- [CPHI & PMEC China](https://qbdgroup.com/en/events/cphi-pmec-china-2026) — 2026-02-17 · Medical Devices
  CPHI & PMEC China expo in Shanghai.
- [EuroPCR 2026](https://qbdgroup.com/en/events/europcr-2026) — 2026-02-17 · Medical Devices
  EuroPCR interventional cardiology course in Paris.
- [UK Biotech Day 2026](https://qbdgroup.com/en/events/uk-biotech-day-2026) — 2026-02-17 · Pharma & Biotech
  UK Biotech Day in London.

## Expert Authors

Named QbD Group experts whose bylines appear on the content above:

- [Agustín Conesa](https://qbdgroup.com/en/author/agustin-conesa)
- [Albert Verschoor](https://qbdgroup.com/en/author/albert-verschoor) — Founder and Managing Director (in memoriam)
- [Alexander Pieters](https://qbdgroup.com/en/author/alexander-pieters)
- [Alissa de Koning](https://qbdgroup.com/en/author/alissa-de-koning) — Life Science Expert at QbD Group
- [Almudena del Castillo](https://qbdgroup.com/en/author/almudena-del-castillo) — Division Head Vigilance
- [Almudena Soriano](https://qbdgroup.com/en/author/almudena-soriano) — Senior Consultant Drug Safety at QbD Group
- [An-Katrien Pauwels](https://qbdgroup.com/en/author/an-katrien-pauwels)
- [Ana María González Fuente](https://qbdgroup.com/en/author/ana-maria-gonzalez-fuente)
- [Ana Ortiz](https://qbdgroup.com/en/author/ana-ortiz) — Medical Writer
- [Ana San Martín Cuende](https://qbdgroup.com/en/author/ana-san-mart-n-cuende) — Senior Toxicology Officer
- [Ana San Martín Cuende](https://qbdgroup.com/en/author/ana-san-martin-cuende) — Senior Toxicology Officer
- [Ana Valentina Grados](https://qbdgroup.com/en/author/ana-valentina-grados) — Senior Project Consultant
- [Anam Ahmad](https://qbdgroup.com/en/author/anam-ahmad) — Senior Consultant Safety
- [Andrea Di Luca](https://qbdgroup.com/en/author/andrea-di-luca)
- [Angeles Escartí-Nebot](https://qbdgroup.com/en/author/angeles-escarti-nebot) — Global Head Regulatory Affairs at QbD Group
- [Anne Collard](https://qbdgroup.com/en/author/anne-collard)
- [Anne Paulussen](https://qbdgroup.com/en/author/anne-paulussen) — Senior Consultant IVD - RA
- [Anne-Sophie Grell](https://qbdgroup.com/en/author/anne-sophie-grell) — Business Unit Manager RA MD — PhD Physics, MSc Medical Physics
- [Annelies Rombout](https://qbdgroup.com/en/author/annelies-rombout) — Senior Consultant IVD CRO — 23+ years experience in IVD product development and clinical studies
- [Annelies Rotthier](https://qbdgroup.com/en/author/annelies-rotthier) — Business Unit Manager IVD CRO — 15 years of experience in IVD field
- [Arie Goossens](https://qbdgroup.com/en/author/arie-goossens)
- [Ayelen Gaitan](https://qbdgroup.com/en/author/ayelen-gaitan) — Clinical Project Manager — Clinical Research | Medical Devices
- [Bart Crommelinck](https://qbdgroup.com/en/author/bart-crommelinck) — Chief Operating Officer
- [Bart Van Acker](https://qbdgroup.com/en/author/bart-van-acker) — Founder and Managing Director — BioEng
- [Belkis Lanza](https://qbdgroup.com/en/author/belkis-lanza)
- [Bianca van de Swaluw](https://qbdgroup.com/en/author/bianca-van-de-swaluw) — Senior Life Science Consultant at QbD Group
- [Carol Lazović](https://qbdgroup.com/en/author/carol-lazovic) — Clinical Strategy BD Senior Manager
- [Caroline Aernouts](https://qbdgroup.com/en/author/caroline-aernouts) — Senior Consultant Regulatory Affairs, Medical Devices
- [Charline Borghgraef](https://qbdgroup.com/en/author/charline-borghgraef)
- [Christelle Marlet](https://qbdgroup.com/en/author/christelle-marlet)
- [Claire Pietermans](https://qbdgroup.com/en/author/claire-pietermans)
- [Claudia Monteiro Tomas](https://qbdgroup.com/en/author/claudia-monteiro-tomas) — Clinical Project Manager
- [Claudia Wever](https://qbdgroup.com/en/author/claudia-wever) — Project Manager
- [Conny Van Loon](https://qbdgroup.com/en/author/conny-van-loon)
- [David García](https://qbdgroup.com/en/author/david-garcia)
- [Delphine Malisse](https://qbdgroup.com/en/author/delphine-malisse) — Head of Quality Assurance Clinical — MRQA
- [Diane Fairweather](https://qbdgroup.com/en/author/diane-fairweather) — Clinical Lead — PhD
- [Djordje Lazovic](https://qbdgroup.com/en/author/djordje-lazovic) — Orthopedic Surgeon & Professor
- [Dmitry Obolskiy](https://qbdgroup.com/en/author/dmitry-obolskiy) — Senior Consultant RA | Team Lead | Associate Director
- [Dominiek Rossillion](https://qbdgroup.com/en/author/dominiek-rossillion) — Division Head Quality Assurance at QbD Group
- [Dr. Ángel Navarro Lima](https://qbdgroup.com/en/author/dr-angel-navarro-lima)
- [Dr. Antonio Borregón](https://qbdgroup.com/en/author/antonio-borregon) — Head Global Business Development Pharma
- [Dr. Laura Fragata Tavares](https://qbdgroup.com/en/author/laura-fragata-tavares) — Pharmacovigilance Consultant
- [Dr. Richard Habis](https://qbdgroup.com/en/author/richard-habis) — Expert in Biopharmaceutical Consulting and Market Research
- [Egbert Smit](https://qbdgroup.com/en/author/egbert-smit) — CEO, MLA Diagnostics
- [Elena Isabel Nieves](https://qbdgroup.com/en/author/elena-isabel-nieves) — Toxicology Expert
- [Elena Nieves](https://qbdgroup.com/en/author/elena-nieves)
- [Elias Muys](https://qbdgroup.com/en/author/elias-muys) — Associate Consultant, QbD Group
- [Ellen Neven](https://qbdgroup.com/en/author/ellen-neven)
- [Elly De Bruyn](https://qbdgroup.com/en/author/elly-de-bruyn) — Chief Human Resources Officer
- [Emin Oglou](https://qbdgroup.com/en/author/emin-oglou) — Consultant, QbD Group
- [Emma Buchet](https://qbdgroup.com/en/author/emma-buchet)
- [Eric Barrera](https://qbdgroup.com/en/author/eric-barrera) — Life Sciences Consultant at QbD Group
- [Erwin van der Pijl](https://qbdgroup.com/en/author/erwin-van-der-pijl) — Project Manager at QbD Group
- [Estefanía Rodriguez](https://qbdgroup.com/en/author/estefan-a-rodriguez) — Senior Drug Safety Officer
- [Eva-Lynn Vanautgaerden](https://qbdgroup.com/en/author/eva-lynn-vanautgaerden)
- [Evan Claes](https://qbdgroup.com/en/author/evan-claes)
- [Evelien Cools](https://qbdgroup.com/en/author/evelien-cools) — Industry Lead Life Sciences — delaware
- [Filip Dosselaere](https://qbdgroup.com/en/author/filip-dosselaere) — Chief Commercial Officer
- [Filip Heitbrink](https://qbdgroup.com/en/author/filip-heitbrink) — CEO — Scilife
- [Frederik Schietekat](https://qbdgroup.com/en/author/frederik-schietekat)
- [Gabriela Rosina Arequipa Rivera](https://qbdgroup.com/en/author/gabriela-rosina-arequipa-rivera)
- [Geert Vandenbossche, PhD](https://qbdgroup.com/en/author/geert-vandenbossche) — Founder & Owner, C&E Solutions
- [Gijs Klarenbeek](https://qbdgroup.com/en/author/gijs-klarenbeek) — Physician & Clinical Development Expert
- [Gisela Moreno](https://qbdgroup.com/en/author/gisela-moreno)
- [Gorka Ibaibarriaga Ruiz](https://qbdgroup.com/en/author/gorka-ibaibarriaga-ruiz)
- [Héctor Fuentes de la Osa](https://qbdgroup.com/en/author/hector-fuentes-de-la-osa)
- [Heleen De Schrijver](https://qbdgroup.com/en/author/heleen-de-schrijver)
- [Igor Excelmans](https://qbdgroup.com/en/author/igor-excelmans) — Life Science Consultant at QbD Group
- [Isabelle De Bock](https://qbdgroup.com/en/author/isabelle-de-bock) — Clinical Strategy BD Senior Manager
- [Jan Appelmans](https://qbdgroup.com/en/author/jan-appelmans) — Senior Consultant Software Services at QbD Group
- [Javier López](https://qbdgroup.com/en/author/javier-lopez) — Toxicology Expert
- [Jeroen Leemen](https://qbdgroup.com/en/author/jeroen-leemen) — Quality & Compliance Engineer — B.A.Sc. Biomedical Sciences
- [Jeroen Verhoeven](https://qbdgroup.com/en/author/jeroen-verhoeven)
- [Jo Doucet](https://qbdgroup.com/en/author/jo-doucet) — Global Head Qualification & Validation
- [Joanna Kurek](https://qbdgroup.com/en/author/joanna-kurek)
- [Joanna Popiołkiewicz](https://qbdgroup.com/en/author/joanna-popiolkiewicz) — Scientific and Business Development Director, QPPV
- [Joanna Rapacz](https://qbdgroup.com/en/author/joanna-rapacz) — CMC and RA Director & Qualified Person
- [Jonathan Boel](https://qbdgroup.com/en/author/jonathan-boel) — Global Head Software Solutions & Services at QbD Group
- [Jorge Luis Rojas Caicedo](https://qbdgroup.com/en/author/jorge-luis-rojas-caicedo) — Líder de Proyectos QbD Suramérica
- [Jos Van Herreweghe](https://qbdgroup.com/en/author/jos-van-herreweghe)
- [Jose María Montes](https://qbdgroup.com/en/author/jose-mar-a-montes) — Associate Drug Safety at QbD Group
- [Judith Prevoo](https://qbdgroup.com/en/author/judith-prevoo) — Quality Assurance, QbD Group
- [Jules Petit](https://qbdgroup.com/en/author/jules-petit) — GenDx
- [Julie Hendrickx](https://qbdgroup.com/en/author/julie-hendrickx) — MD CRO Project Management Lead
- [Karen De Man](https://qbdgroup.com/en/author/karen-de-man)
- [Karen Lizeth Obando](https://qbdgroup.com/en/author/karen-lizeth-obando) — Commercial Manager
- [Karisia Wouters](https://qbdgroup.com/en/author/karisia-wouters) — Project Manager
- [Katheryn Oyola](https://qbdgroup.com/en/author/katheryn-oyola)
- [Katheryn Vanessa Oyola](https://qbdgroup.com/en/author/katheryn-vanessa-oyola) — Operations Manager en QbD Group Suramérica
- [Kim Stevens](https://qbdgroup.com/en/author/kim-stevens) — Scientific Copywriter and Project Manager
- [Kirsten Van Garsse](https://qbdgroup.com/en/author/kirsten-van-garsse) — Business Unit Manager RA IVD & Representative Services — MSc Biomedical Sciences
- [Koen Laenen](https://qbdgroup.com/en/author/koen-laenen) — RA Manager Pharma at QbD Group
- [Kristof Vanschoonbeek](https://qbdgroup.com/en/author/kristof-vanschoonbeek) — Team Lead Clinical Operations - Medical Affairs Coordinator
- [Laura Drikite](https://qbdgroup.com/en/author/laura-drikite) — Clinical Project Manager
- [Laura Hernández Jiménez](https://qbdgroup.com/en/author/laura-hern-ndez-jim-nez) — Drug Safety Officer
- [Leen De Taeye](https://qbdgroup.com/en/author/leen-de-taeye) — Clinical Research Professional
- [Leslie Cisneros](https://qbdgroup.com/en/author/leslie-cisneros) — Validation & Qualification Specialist at QbD Group
- [Lieve De Wolf](https://qbdgroup.com/en/author/lieve-de-wolf) — ATMP Expert at QbD Group
- [Lina Marcela Kreisberger Rivera](https://qbdgroup.com/en/author/lina-marcela-kreisberger-rivera) — Líder de Proyectos en QbD Group Suramérica
- [Lotte Essers](https://qbdgroup.com/en/author/lotte-essers) — ATMP Expert at QbD Group
- [Luciano García](https://qbdgroup.com/en/author/luciano-garcia)
- [Maaike Tuinsma](https://qbdgroup.com/en/author/maaike-tuinsma) — Regulatory Affairs
- [Mae Ann Belandres](https://qbdgroup.com/en/author/mae-ann-belandres) — Senior Consultant Toxicology — ERT (EUROTOX Registered Toxicologist)
- [Marco Ricci](https://qbdgroup.com/en/author/marco-ricci)
- [María Corrales](https://qbdgroup.com/en/author/maria-corrales) — Team Lead and Project Manager, Medical Information, QbD Group
- [María Dago Requena](https://qbdgroup.com/en/author/maria-dago-requena)
- [Maria Fossati](https://qbdgroup.com/en/author/maria-fossati)
- [María José Villarroel](https://qbdgroup.com/en/author/maria-jose-villarroel) — Toxicology & Quality Director — Toxicology & Quality Director at QbD Group
- [Marin Vrhovac](https://qbdgroup.com/en/author/marin-vrhovac) — Business Development Manager Pharma
- [Marjoke Le Roy](https://qbdgroup.com/en/author/marjoke-le-roy) — Junior Scientific Copywriter
- [Marta Klepczyńska](https://qbdgroup.com/en/author/marta-klepczynska) — Head of CMC Department & Qualified Person
- [Marta Uceda Martín](https://qbdgroup.com/en/author/marta-uceda-martin)
- [Martijn Reniers](https://qbdgroup.com/en/author/martijn-reniers) — Chief Innovation Officer
- [Martine Suckers](https://qbdgroup.com/en/author/martine-suckers)
- [Matthias Bellmann](https://qbdgroup.com/en/author/matthias-bellmann) — MDR Notified Body — TÜV SÜD
- [Matthias Marivoet](https://qbdgroup.com/en/author/matthias-marivoet) — Senior Quality Management Expert
- [MCarme Montull](https://qbdgroup.com/en/author/mcarme-montull)
- [Michaël Hooreman](https://qbdgroup.com/en/author/michael-hooreman)
- [Michaël Vandezande](https://qbdgroup.com/en/author/michael-vandezande) — COO — ZiggZagg
- [Miguel Gutierrez](https://qbdgroup.com/en/author/miguel-gutierrez) — Consultant RA Pharma
- [Mike Duijkers](https://qbdgroup.com/en/author/mike-duijkers)
- [Mónica Lopez](https://qbdgroup.com/en/author/monica-lopez)
- [Nadia Bouhjar](https://qbdgroup.com/en/author/nadia-bouhjar)
- [Natalia Herrera](https://qbdgroup.com/en/author/natalia-herrera) — Sales Specialist Toxicology
- [Pablo Palomar](https://qbdgroup.com/en/author/pablo-palomar) — Senior Toxicology Officer
- [Pablo Palomar Llorente](https://qbdgroup.com/en/author/pablo-palomar-llorente) — Senior Toxicology Officer
- [Patricia Giulietta Lugo Mariani](https://qbdgroup.com/en/author/patricia-giulietta-lugo-mariani)
- [Peter Fry](https://qbdgroup.com/en/author/peter-fry) — Country Manager UK at QbD Group
- [Petra De Geest](https://qbdgroup.com/en/author/petra-de-geest) — Business Unit Manager Medical Affairs
- [Pia Gyselen](https://qbdgroup.com/en/author/pia-gyselen) — Lead Medical Writer
- [Pierfrancesco Agostoni](https://qbdgroup.com/en/author/pierfrancesco-agostoni) — Interventional Cardiologist
- [Pieter Bogaert](https://qbdgroup.com/en/author/pieter-bogaert) — Senior Consultant IVD – Regulatory Affairs — PhD Biotechnology
- [Pieter Gibens](https://qbdgroup.com/en/author/pieter-gibens)
- [Pieter Smits](https://qbdgroup.com/en/author/pieter-smits) — Project Manager at QbD Group
- [QbD Group](https://qbdgroup.com/en/author/qbd-group)
- [Rahima Garbaoui](https://qbdgroup.com/en/author/rahima-garbaoui) — Life Science Consultant at QbD Group
- [Ramiro Murillo](https://qbdgroup.com/en/author/ramiro-murillo) — Qualification & Validation Expert
- [Rik Seymus](https://qbdgroup.com/en/author/rik-seymus)
- [Roberta Sgammato](https://qbdgroup.com/en/author/roberta-sgammato)
- [Rodrigo Mondelo Ripoll](https://qbdgroup.com/en/author/rodrigo-mondelo-ripoll) — Senior Consultant Qualification & Validation
- [Sacha Lynch](https://qbdgroup.com/en/author/sacha-lynch) — Director Regulatory Affairs UK
- [Salim Cali](https://qbdgroup.com/en/author/salim-cali) — Regulatory Affairs Consultant at QbD Group
- [Salma Michor](https://qbdgroup.com/en/author/salma-michor) — Division Head Regulatory Affairs — PhD in Bio Engineering, MSc Food & Biotechnology, MSc King's College London, MBA Open University, RAC (EU & Global), Cha
- [Sandra Paredes](https://qbdgroup.com/en/author/sandra-paredes) — Quality Assurance Coordinator
- [Sandy Adjemian](https://qbdgroup.com/en/author/sandy-adjemian) — Senior Medical Writer
- [Sara Peeters](https://qbdgroup.com/en/author/sara-peeters) — Senior Consultant IVD CRO — 15+ years experience in point-of-care and IVD development
- [Sara Vandyck](https://qbdgroup.com/en/author/sara-vandyck) — Life Science Consultant at QbD Group
- [Sarah Andries](https://qbdgroup.com/en/author/sarah-andries) — Clinical Regulatory Manager
- [Sarah Schouteden](https://qbdgroup.com/en/author/sarah-schouteden)
- [Sebastian Miranda](https://qbdgroup.com/en/author/sebastian-miranda) — CSV & Data Integrity Consultant
- [Sergio Molina](https://qbdgroup.com/en/author/sergio-molina)
- [Siebe Timmerman](https://qbdgroup.com/en/author/siebe-timmerman)
- [Sophie Achten](https://qbdgroup.com/en/author/sophie-achten) — Senior Clinical Project Manager — Clinical Operations | Medical Devices & IVDs
- [Sophie Missotten](https://qbdgroup.com/en/author/sophie-missotten)
- [Soraia Teresa Ferreira Dos Santos](https://qbdgroup.com/en/author/soraia-teresa-ferreira-dos-santos) — Senior Drug Safety Officer at QbD Group
- [Stan Van Kerkhoven](https://qbdgroup.com/en/author/stan-van-kerkhoven) — Senior Project Manager Qualification & Validation
- [Stella Grigoriou](https://qbdgroup.com/en/author/stella-grigoriou) — Specialist RA Pharma at QbD Group
- [Stéphane Liévin](https://qbdgroup.com/en/author/stephane-lievin)
- [Steven Van Hove](https://qbdgroup.com/en/author/steven-van-hove)
- [Stijn Lagaert](https://qbdgroup.com/en/author/stijn-lagaert) — European and Belgian Patent Attorney, European Patent Litigator and Partner — Gevers
- [Stijn Paridaens](https://qbdgroup.com/en/author/stijn-paridaens) — CEO — ZiggZagg
- [Thalysia Larosse](https://qbdgroup.com/en/author/thalysia-larosse) — Quality management specialist
- [Thomas Mennens](https://qbdgroup.com/en/author/thomas-mennens)
- [Tiago de Matos Lourenço](https://qbdgroup.com/en/author/tiago-de-matos-lourenco) — Quality Assurance Lead — Quality Assurance Lead
- [Tom Lokermans](https://qbdgroup.com/en/author/tom-lokermans) — Chief Financial Officer
- [Tommy Heck](https://qbdgroup.com/en/author/tommy-heck) — Digital Twin and Modeling Architect
- [Vic Ampen](https://qbdgroup.com/en/author/vic-ampen)
- [Vincent Van Fulpen](https://qbdgroup.com/en/author/vincent-van-fulpen)
- [Ward Neefs](https://qbdgroup.com/en/author/ward-neefs) — Life Science Consultant at QbD Group
- [Willem Orye](https://qbdgroup.com/en/author/willem-orye)
- [Wim Steenackers](https://qbdgroup.com/en/author/wim-steenackers)
- [Wout Vertenten](https://qbdgroup.com/en/author/wout-vertenten) — Pharmaceutical Consultant at QbD Group
- [Xi Li](https://qbdgroup.com/en/author/xi-li) — RA Specialist
- [Yanis Soufyani](https://qbdgroup.com/en/author/yanis-soufyani) — Life Science Consultant at QbD Group
- [Yiolina Sarri](https://qbdgroup.com/en/author/yiolina-sarri)
- [Yosri El-Achheb](https://qbdgroup.com/en/author/yosri-el-achheb) — Senior Business Development Manager MedTech
- [Yves Dène](https://qbdgroup.com/en/author/yves-dene)
- [Yves Peeraer](https://qbdgroup.com/en/author/yves-peeraer) — Division Head Lab Services — MP, QP

## Machine-Readable Sources

- [Sitemap](https://qbdgroup.com/sitemap.xml): Every indexable URL across EN/ES/ZH-CN.
- [llms-full.txt](https://qbdgroup.com/llms-full.txt): Full content index with summaries.
- Markdown mirrors: prefix any article path with `/md` to get the full body as plain Markdown
  (no JavaScript required). Example: https://qbdgroup.com/en/blog/<slug> → https://qbdgroup.com/md/en/blog/<slug>.
  Works for /blog, /regulatory-updates, /case-studies, /whitepapers, /downloads, /news, /webinars and /events
  in all three languages, and each file starts with YAML front matter (title, url, author, published, citation).
- [Blog RSS](https://qbdgroup.com/rss.xml?feed=blog): Latest articles.
- [Regulatory RSS](https://qbdgroup.com/rss.xml?feed=regulatory): Latest regulatory updates.
- [All content RSS](https://qbdgroup.com/rss.xml?feed=all): Combined feed.

## Citation

Cite content as: QbD Group, "<page title>", https://qbdgroup.com<path>. Attribution to the named author on the
page is preferred where one is listed. Content is free to read and quote with a link back to the source page.

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Generated 2026-09-10T13:53:09.460Z · maintained at https://qbdgroup.com/llms-full.txt