Knowledge center

Explore our knowledge center, your go-to resource for insights and expertise in the field of life sciences. Here, you'll find a wealth of information, from in-depth whitepapers and blog articles to case studies, webinars, and regulatory updates.

Whether you're in pharma, biotech, medical devices, or any other industry, our diverse services and expert guidance are designed to keep you informed and ahead of industry trends. Dive into our content and stay connected with the latest advancements and best practices.

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Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

21 CFR Part 11 compliance checklist

Want to assess whether a computer system generates electronic records and uses electronic signatures, and whether the system complies with Part 11 of 21 CFR? Download this free checklist.

Whitepaper

Achieving laboratory compliance

This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.

Whitepaper

A Complete Guide to Computer System Validation

This guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems. Download now.

Whitepaper

Analytical Method Validation

In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.

Whitepaper

Annual Product Quality Review in Pharma

Want to learn more about the importance, benefits, and key challenges related to the Annual Product Quality Review in Pharma? Then read on quickly!

Whitepaper

ISO 13485:2016 - Compliance Checklist

Are you up to date with the latest medical device QMS requirements? Download our free ISO 13485:2016 checklist to ensure compliance.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

Digital Health - Exploring the landscape and future opportunities

This whitepaper informs you about digital health, key technology pillars, and new opportunities to anticipate future trends in your healthcare sector.

Whitepaper

Ensuring compliance and quality in Pharmacovigilance

The whitepaper emphasizes the importance of a robust pharmacovigilance QMS and a well-maintained Pharmacovigilance System Master File (PSMF). Download now.

Whitepaper

EUDRALEX Volume 4 Annex 11 Compliance Checklist

Assess your computer system's compliance with EudraLex Volume 4 Annex 11 guidelines using our checklist. Download now for GMP assurance.

Whitepaper

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

This white paper explores why IT is shifting to agile, focuses on the prevalent Scrum methodology, and concludes with guidance on adapting system validation processes.

Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.

Whitepaper

GAMP categories for computerized systems: what are they and what are they for?

In this whitepaper, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.

Whitepaper

ICH Stability Studies on Pharmaceuticals

This whitepaper discusses the importance of different methods for testing the stability of pharmaceutical products, stability study guidelines, and other aspects related to the stability of...

Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

New GMP Facility Qualification: set-up, process and best practices

This whitepaper delves into the challenges of establishing a new GMP facility, focusing on potential pitfalls and best practices. Download now.

Whitepaper

Organic and mutagenic impurities in pharma

Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Whitepaper

Standards and regulations for software used in Medical Devices

Explore the essential standards and regulations for software used in Medical Devices, including IEC 62304 and IEC 82304. Download now.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.

Whitepaper

The One-Vigilance strategic roadmap to corporate excellence

This whitepaper introduces the concept of One Vigilance within the context of the current drug safety landscape. Download now.

Whitepaper

EU GMP: How to import your products into the EU?

Are you a medicinal product manufacturer looking to import your products into the EU in line with the latest EU-GMP import regulations? Download our guide.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

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...

Case study

Ensuring pharmaceutical production quality: cleaning validation for government agency

Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.

Case study

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

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.

Case study

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.

Case study

Help BioLizard build their Quality Management System

QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.

Case study

Helping Abraca BioSystems to obtain ISO 13485 certification

QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.

Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.

Case study

Patient Support Program (PSP)

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.

Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

Case study

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

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).

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Case study

Supporting Oncomfort in developing and certifying their ISO 13485 QMS

QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.

Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.

Webinar

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

Discover strategies for establishing a compliant and successful ATMP Quality Management System. Watch our webinar on demand.

Webinar

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Explore the transformative ATMP journey and vein-to-vein strategy in our webinar. Learn how to navigate challenges and unlock the full potential of ATMPs.

Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Webinar

How to manage mandatory communication of Toxicological Risks?

Learn how to effectively manage toxicological risks in the pharmaceutical industry by addressing, reporting, and mitigating potential harm.

Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.

Webinar

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Learn how to launch your Medical Device Software successfully with expert insights on market access and commercialization strategies. Watch our webinar on demand.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.

Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.

Webinar

The Basic Concepts of the QbD Methodology

Learn the basics of QbD methodology with industry experts in this on-demand webinar.

Webinar

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

This webinar on demand will tell you more about the second edition of GAMP 5.

Webinar

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

Explore how drug safety teams can transform into proactive benefit drivers with the right tools & resources in this webinar on demand.

Webinar

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

Explore the impact of Artificial Intelligence and Machine Learning on medical device validation and verification processes.

Webinar

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

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...

Whitepaper

Medical Device Regulation (MDR) Checklist

Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.

Whitepaper

How to keep computerized systems in the operational phase

Ensure compliance and efficiency with best practices for maintaining computerized systems in the operational phase. Download our expert whitepaper now!

Case study

Scalable MSAT validation support for seamless compliance & efficiency

Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.

Case study

Restoring manufacturing timelines through expert deviation management

Discover how QbD Group helped a leading biotechnology company overcome a backlog of deviations, restoring timely batch release through expert QA support.

ATMP production sites commissioning & qualification

Case study

Guiding a global biotech company through ATMP facility qualification

Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.

Cleaning Validation - Lab Services - QbD Group

Case study

Enhancing data integrity & aseptic manufacturing compliance

QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.

Case study

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.

Webinar

Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

This webinar aims to provide a comprehensive overview of Extractables and Leachables (E&L) in pharmaceutical products, highlighting regulatory complexities, toxicological challenges, and practical...

Webinar

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Explore pharmacovigilance in cell, CAR T, and RNA therapies. Join our webinar to tackle tomorrow’s drug safety and risk management challenges.

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Client Case - Autoclave validation and integration - QbD Group

Case study

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.

Blog

Environmental Risk Assessment (ERA) in Drug Products: Understanding the New EMA Guideline Updates

Learn how the EMA’s updated 2024 guideline changes Environmental Risk Assessment (ERA) for drug products. Discover key phases, risks, and industry impact.

Blog

Outsourced QA: Benefits, Risks, and Long-Term Impact

Outsourcing QA can reduce costs and boost quality, but also brings risks. Learn how to choose the right partner and manage outsourced QA effectively.

Blog

IVDR Compliance for Large-Panel Next-Generation Sequencing (NGS) Devices: A Strategic Guide

Achieve IVDR compliance for large-panel Next-Generation Sequencing (NGS). Validate genetic variants and meet performance requirements with the right strategy.

Blog

Life Sciences Digitization: Your Compliance Roadmap

Discover how digitization in the life sciences boosts efficiency, ensures data integrity, and strengthens regulatory compliance. Partner with QbD’s experts for...

Blog

The Triangle Dilemma of Quality, Cost & Time in GMP Laboratories

Learn how GMP labs can strategically balance quality, cost, and time using smart technologies, risk-based approaches, and lean workflows.

Blog

Pharmacovigilance Is a Shared Responsibility: Why Adverse Events Reporting Matters More Than Ever

Discover how healthcare professionals and patients contribute to drug safety by reporting adverse events, an essential part of pharmacovigilance that helps...

Blog

Drowning in APR/PQR Work? Here’s How to Lighten the Load.

APR/PQR season doesn't have to be a burden. Discover 5 practical strategies to ease the load and stay compliant—plus how QbD Group can support you.

Blog

Patient Enrolment and Retention in Clinical Trials: How to Improve Recruitment and Keep Patients Engaged

Learn key strategies to boost patient enrolment and retention in clinical trials—from clear criteria and site engagement to patient-centric trial design.

Blog

Can IVDR Be Your Global Regulatory Compass for Market Entry?

Learn how IVDR aligns with FDA standards, where they diverge, and how to use your IVDR compliance as a springboard for global IVD market access.

Blog

Clinical Trial Site Selection and Qualification: A Practical Guide

Learn the essential steps and key considerations for effective clinical trial site selection and qualification. Optimize timelines, budget, and compliance.

Blog

Local Pharmacovigilance Matters: Where Global Strategy Meets On-the-Ground Reality

Global PV success requires more than compliance. Discover how hybrid pharmacovigilance models help pharma companies meet local regulatory demands and build...

Blog

How to Transform Pharmacovigilance into a Growth Strategy

Learn how to optimize pharmacovigilance systems and outsource strategically to turn compliance into business growth.

Blog

The role of Good Distribution Practices (GDP) and Quality Risk Management (QRM) in ensuring pharmaceutical integrity

Learn how Good Distribution Practices (GDP) and Quality Risk Management (QRM) ensure the integrity, safety, & compliance of pharma products during distribution.

Blog

Risk Management in Clinical Trials: Assessment & Mitigation Strategies

Learn how to proactively identify, assess, and mitigate the top risks in clinical trials. Expert tips on regulatory compliance, RBM, QRM tools & best practices.

Blog

eCTD Publishing: 10 Tips for a Smooth Submission Process

Learn how to streamline your eCTD publishing and submissions with 10 expert tips. Avoid pitfalls, ensure compliance, and meet global regulatory requirements.

Blog

Contamination Control Strategy (CCS): a key requirement in the new Annex 1

Learn how to build a contamination control strategy (CCS) under Annex 1. Key elements, scope, risk control, and inspection-readiness tips included.

Blog

Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?

IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these...

Blog

Vaccine Safety and Pharmacovigilance: ESAVI & EU Tools

Explore how ESAVI monitoring, EU initiatives, and pharmacovigilance systems contribute to vaccine safety throughout the product lifecycle.

Blog

IMPD Clinical Trials: key quality considerations for regulatory success

Prepare a compliant IMPD for clinical trials. Avoid delays with expert tips on quality documentation, common pitfalls, and regulatory expectations.

Blog

Cleaning Validation in Pharma: Strategy & Best Practices

Cleaning validation ensures product safety in pharma. Discover types, methods, MACO limits, and how to build an efficient strategy with worst-case selection.

Blog

Smarter audit planning and management in life sciences: stay compliant, save time

Improve audit planning, execution, and follow-up in life sciences with a structured, risk-based approach—plus when and why to consider external QA support.

Blog

How Veterinary Pharmacovigilance Supports Global Health Through Audits

Veterinary pharmacovigilance audits are key to global health. Discover how QbD helps you comply with VGVP and ensure veterinary drug safety.

Blog

The New Rules for Monitoring Critical Medicines: Safeguarding Europe’s Medicine Supply

Discover how the EU’s Critical Medicines Act and ESMP aim to prevent drug shortages and build a resilient medicine supply for Europe’s future.

Blog

Why Extractables and Leachables Matter in Pharma Risk Assessments

Extractables and leachables can impact drug safety and stability. Learn what they are, why they matter, and how they are assessed in pharmaceutical...

Blog

GMP Annex 21: key requirements for importing medicines into the EU

Learn the key requirements of GMP Annex 21 for importing medicines into the EU, including MIA compliance, QP certification, and supply chain responsibilities.

Blog

Sub-visible particles in pharmaceutical products: understanding EP General Chapter 2.9.19

Learn how General Chapter 2.9.19 regulates sub-visible particle testing in injectables. Discover methods, acceptance criteria, and contamination control...

Blog

Analytical Method Transfer under GMP: tips & pitfalls

Ensure smooth GMP-compliant analytical method transfers with these key tips. Avoid delays by tackling common pitfalls and boosting QC reliability.

Blog

How QPs Verify GMP Compliance for Non-EU Manufactured Products

Qualified Persons (QPs) verify GMP compliance for non-EU products by following Annex 16, Annex 21, and EU testing requirements. Here'showthey do it.

Blog

Analytical Method Transfer: a practical step-by-step guide to compliance and efficiency

Learn the 4 key steps of Analytical Method Transfer (AMT), strategies, and compliance tips to ensure a smooth and GMP-compliant transfer process.

Blog

ICP-MS vs ICP-OES analysis: choosing the right elemental impurity testing method

Learn the differences between ICP-MS and ICP-OES for elemental impurity testing. Compare sensitivity, cost, and regulatory compliance to make the best choice.

Blog

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

Blog

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

What is post-market surveillance and post-market clinical follow-up for medical devicesunder the MDR in the EU, and how can QbD help?

Blog

EU-QPPV registration and local pharmacovigilance contacts: what you need to know

Understand the process for EU-QPPV registration and the role of local pharmacovigilance contacts to ensure compliance with European Union regulations.

Blog

Pharmacovigilance Agreements (PVA) simplified: key requirements and best practices for compliance

Learn the essentials of Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA) to ensure regulatory compliance and effective...

Blog

Container Closure Integrity Testing (CCIT): why it’s essential for pharmaceutical packaging

Learn how Container Closure Integrity Testing (CCIT) safeguards pharmaceutical packaging, ensuring sterility, safety, and compliance with advanced...

Blog

Quality Audits Management: Quality Audits managed according to QMS

GxP audits are the backbone of compliance and improvement. From risk-based planning to meticulous execution and compliance review, each step ensures...

Blog

Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights

Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.

Blog

Operational software compliance that adds value: essential pharma Q&A

Explore how pharma companies can make software compliance a value-adding asset, enhancing efficiency, data security, and regulatory adherence.

Blog

Operational software compliance in pharma: a practical guide

Discover a comprehensive approach to maintaining software compliance in pharma. Explore compliance frameworks, key stakeholder roles, task management, and best...

Blog

Essential steps for pharma software compliance in the operational phase

Explore essential steps to maintain compliance in pharmaceutical software, from periodic reviews to change control, ensuring data integrity and safety.

Blog

How to avoid non-compliance in the pharmaceutical industry

This blog underscores the critical nature of regulatory compliance in the pharmaceutical industry. It stresses the importance of senior management's commitment...

Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

Discover why usability testing is essential for compliance and safety in Near-Patient and self-testing devices under the IVDR. Learn key guidelines, study...

Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

Compliance with Annex XIV is essential for certain IVD performance studies under the IVDR, such as those involving surgically invasive sampling or...

Blog

What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

The introduction of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has reshaped how in vitro diagnostic (IVD) devices are regulated in Europe. With a...

Blog

5 Key Toxicological Monitoring Tests for Regulatory Compliance

Explore essential toxicological monitoring tests, including E&L, Nitrosamine Analysis, and Ames Test, to ensure safety and meet regulatory standards.

Blog

Pharmacovigilance (PV) Safety Databases: Why They Matter and How to Choose the Right One

Learn the key functions of PV safety databases, why they are crucial for patient safety and compliance, and how to choose the right one for your organization.

Blog

How to define your Clinical Performance Strategy?

Defining a clinical performance strategy for an in vitro diagnostic (IVD) device requires a structured approach. A solid strategy helps you stay focused and...

Blog

Understanding REACH Registration for Chemicals in Pharma

REACH registration is more than just a regulatory box to check — it's a crucial step for companies in the pharma, life sciences, and chemical industries...

Blog

Why is Clinical Performance key to a successful IVDR submission?

Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we'll explore the role of...

Blog

Sterilization Validation: A Practical Guide to Ensuring Safety and Compliance

Ensure product safety with effective sterilization validation. Learn key steps, methods, and challenges to meet regulatory standards in healthcare and pharma.

Blog

15 Years of ATMPs – Reflecting on the Past, Shaping the Future

Advanced Therapy Medicinal Products (ATMPs) have revolutionized medicine, offering new treatments for once untreatable conditions. The recent CAT Scientific...

Blog

Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma

Learn how periodic validation reviews maintain pharma system compliance, using risk-based analysis and real-time monitoring to ensure continuous improvement

Blog

Technovigilance in Action: Safeguarding Health with Post-Market Surveillance of Medical Devices

Learn how technovigilance ensures medical device safety through post-market surveillance, tackling risks, compliance, and best practices.

Blog

Why Combining Scripted and Unscripted Testing Boosts Your CSV Strategy

Discover how combining unscripted and scripted testing ensures robust Computer System Validation (CSV) for compliance, accuracy, and system reliability.

Blog

The Rise of Knowledge Process Outsourcing in Drug Safety: Smarter Outsourcing for Safer Healthcare

Discover how strategic knowledge process outsourcing (KPO) is revolutionizing pharmaceutical drug safety departments, driving efficiency and innovation.

Blog

Stay Ahead of Compliance: How to Effectively Manage Your Yearly Audits

Manage yearly audits to ensure compliance and quality in pharma and medical devices. Learn key strategies and boost your QMS now!

Blog

Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures

Explore essential insights into the EMA Linguistic Review process for Product Information of medicinal products approved via the Centralised Procedure.

Blog

Accurate but appealing: How our scientific copywriters and designers collaborate to create captivating content

Effective communication can be the key to unlocking your company's full communication potential, and that's where skilled science writers come in, bridging the...

Blog

Outsourcing Internal Audits: Benefits and Process Optimization in Your Pharma Company

Discover how outsourcing internal audits in your pharma company can boost compliance, optimize resources, and provide fresh, unbiased insights for continuous...

Blog

Why scientists turn to communication: unlocking benefits for Life Sciences companies

Effective communication can be the key to unlocking your company’s full communication potential, and that’s where skilled science writers come in, bridging the...

Blog

The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know

Learn about the risks of benzene contamination in pharmaceuticals, regulatory guidelines, and best practices for ensuring drug safety and quality in...

Blog

Friability and disintegration for oral solid dose forms: the forgotten tests

Discover the crucial role of friability and disintegration tests in ensuring the quality, safety, and effectiveness of pharmaceutical tablets.

Blog

Toxicological Assessment of Extractables and Leachables (E&L)

Learn about Extractables and Leachables in pharmaceuticals, including regulatory guidelines, analytical techniques, and safety assessments.

Blog

Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK

Gain an insightful understanding regarding the current review timelines for clinical trial and amendment applications of the UK Medicines and Healthcare...

Blog

Article 31 Referrals in Pharmacovigilance: A Brief Overview

Learn about the EMA's Article 31 referral procedure for assessing medicine safety and resolving concerns in the EU.

Blog

How to Assess and Improve the Readability of Medicines: A Complete Guide | QbD Group

In the world of medicine, drug readability is a fundamental aspect to ensure safety and patient understanding. The purpose of the consultations is to ensure...

Blog

The Journey from Science to Story

Learn how to transform scientific breakthroughs into compelling stories. Discover strategies to effectively communicate your research to diverse audiences with...

Blog

Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Discover common pitfalls in analytical method transfers and learn strategies to avoid them for seamless drug development and manufacturing processes.

Blog

Elevate Pharma Imports with EU GMP Annexes 16 and 21

Discover how EU GMP Annexes 16 and 21 enhance pharmaceutical import quality and safety. Learn about their global impact on public health.

Blog

The Holy Grail: Achieving Inspection Readiness

Achieving inspection readiness ensures you're always prepared for regulatory inspections. Learn the steps to stay compliant and confident every day.

Blog

Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application

Learn how to implement PIC/S standards in hospital cleanrooms by 2026 to ensure quality, safety, and compliance in pharmaceutical preparations.

Blog

Curb Your Enthusiasm – How to Avoid Rushing into Your Business Development Efforts with Unexpected Cost Consequences

Learn how to strategically plan your business development efforts to avoid unexpected costs and ensure a successful product launch.

Blog

The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation

Explore AI's transformative role in pharmacovigilance in Europe, enhancing drug safety and compliance with EMA regulations through advanced AI tools and...

Blog

In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU

Discover the latest on EU regulations for In-House Devices (IHDs) under IVDR, ISO 15189:2022 updates, and MDCG 2023-1 guidance. Ensure compliance and patient...

Blog

Social Media in Pharmacovigilance: Harnessing Online Conversations for Drug Safety

Explore how social media aids real-time drug safety monitoring and the challenges it presents in pharmacovigilance.

Blog

What to expect when being inspected?

Ever wonder what happens during a regulatory inspection? Let's dive into what to expect, from the inspector's arrival to the post-inspection. Learn how to...

Blog

SCADA Automation in Pharma: Boosting Efficiency and Compliance

Learn how SCADA automation systems revolutionize efficiency and ensure regulatory compliance in pharmaceutical manufacturing.

Blog

Post-Market Success under IVDR: Prioritizing PMS & PMPF

As the IVD industry undergoes significant regulatory changes with the implementation of Regulation (EU) 2017/746 (IVDR), manufacturers are facing new...

Blog

Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Explore how PDE values impact cleaning validation in pharmaceuticals, ensuring safety and compliance with industry standards.

Blog

Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Explore the risks of elemental impurities in drugs and how the ICH Q3D guideline helps ensure product safety and compliance.

Blog

The Crucial Role of Clinical Evidence in IVDR Compliance

This article explores the importance of clinical evidence for In Vitro Diagnostic Medical Devices (IVDs) under the new European Union Regulation (EU) 2017/746...

Blog

Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance

Inspection readiness tips: Learn how to manage fallout and improve with CAPA for better regulatory compliance.

Blog

Why start building IVDR-compliant Technical Documentation now?

Even with the European Commission's proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical...

Blog

Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment

Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological...

Blog

Understanding the European Commission’s proposal for extending the transitional period for IVDs | QbD Group

The European Commission proposes extending the deadlines for complying with the new In Vitro Diagnostic Medical Devices Regulation (IVDR). This article...

Blog

Drug-Device Combination Products and Article 117: How to Stay Compliant?

Discover how to navigate compliance with Article 117 of MDR for drug-device combinations. Ensure correct implementation with essential guidance.

Blog

FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016

Explore the FDA's final rule integrating ISO 13485:2016 into QMSR for medical devices. Understand impacts on manufacturers and how to comply by 2026.

Blog

Patient Support Programs: Enhancing Patient Care through Pharmacovigilance

Discover how Patient Support Programs (PSPs) and Pharmacovigilance enhance patient care, ensuring safety and compliance throughout the healthcare journey.

Blog

IVDR Transitional Extension: Why full speed ahead is still the best strategy

This article explores why staying on track for IVDR compliance is still the best strategy for medical device manufacturers.

Blog

A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings

Gain an insightful understanding into how the MHRA inspect the Pharmacovigilance services of an MAH for post-authorised products.

Blog

Declaration of Equivalence for Medical Devices under the MDR

Discover what is required to declare equivalence under the MDR for medical devices in the EU.

Blog

Impact of the AI Act on the MedTech and Life Sciences Industry

Explore how the AI Act impacts MedTech and Life Sciences, and how the QbD Group can guide you through its complexities.

Blog

The Impact of EU IVDR on Clinical Trials

Blog

MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management

The Medicines and Healthcare Products Regulatory Agency (MHRA) recently announced the upcoming launch of the RegulatoryConnect portal, a groundbreaking step...

Blog

ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline

The new ICH Q2(R2) is a complete revision of the guideline to include more recent application of analytical procedures and to align content with ICH Q14...

Blog

How to create a GMP-Compliant Stability Protocol?

Discover how to create a GMP-compliant stability protocol for pharmaceuticals, ensuring product safety and efficacy throughout its shelf life.

Blog

Digital Therapeutics in the UK: The Post-Brexit Landscape

In this blog post, we delve into the intricacies of Digital Therapeutics (DTx) regulation in the UK, especially in light of Brexit in January 2020.

Blog

Exploring the U.S. Regulatory Framework for Mobile Health

The United States maintains a robust regulatory foundation for Digital Therapeutics (DTx), ensuring that they are supported by stringent regulatory measures,...

Blog

Toxicology Challenges in Pharma: How to Address Them?

Explore how to tackle current and upcoming toxicology challenges in the pharmaceutical industry, ensuring product safety and environmental responsibility.

Blog

Mobile Health Ascending and the WHO’s Global Strategy on Digital Health

Explore the rise of Digital Therapeutics (DTx), covering its regulatory landscape, reimbursement perspectives, applications, and the WHO's vision for digital...

Blog

MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance

Find out what is required to maintain marketing approval for older devices in the EU.

Blog

Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design

When it comes to the regulation of Digital Therapeutics (DTx), Germany is pioneering new paths for its adoption. This blog post delves into the intricacies of...

Blog

The DTx Landscape in Belgium, France, and Their Inspiration from the German Model

In this blog post, we delve into the DTx regulations of Belgium and France, focusing on their reimbursement strategies and providing a glimpse into how other...

Blog

Pharmacovigilance (PV) Audits: importance, process, and challenges

Explore the crucial role of Pharmacovigilance (PV) audits in ensuring drug safety and compliance, the process, and the challenges faced.

Blog

Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success

Quality and Regulatory Affairs: Discover the key elements of Quality Management Systems in the pharmaceutical industry for compliance and success.

Blog

The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape

For DTx manufacturers targeting the European market, compliance with regulation (EU) 2017/745 (MDR) is mandatory. Let’s delve into this regulatory aspect...

Blog

Continuous manufacturing in the pharmaceutical industry: enhancing drug production

Continuous manufacturing in the pharmaceutical industry enhances efficiency and product quality. Learn about CM's implementation, control strategies, and ICH...

Blog

Anticipate the Notified Body Rush: Ensure Timely MDR Compliance

Learn key insights to meet the extended MDR compliance deadlines in time and ensure your device's market access and patient safety.

Blog

MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK

Explore the MHRA's new International Recognition Procedure (IRP) for medicines post-Brexit, and learn how to navigate regulations and the IRP's two assessment...

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Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.

Blog

CE approval for Medical Devices under MDR: key requirements for your device class

Over the past years, the QbD Group has amassed extensive experience in guiding manufacturers towards CE approval for their medical devices, now including...

Blog

Qualifying a new GMP facility: from pitfalls to best practices

On the path to qualifying a new GMP facility? Learn about frequent pitfalls and the best practices we recommend to handle them.

Blog

Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects

Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory...

Blog

Importing medicinal products into the EU? A brief guide to EU GMP compliance.

Are you a medicinal product manufacturer looking to import into the EU in line with EU-GMP import regulations? Be sure to read this article.

Blog

Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA

In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial...

Blog

Understanding plasmids: small molecules with big implications

Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.

Blog

Oncolytic viruses: the use for cancer immunotherapy

Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks,...

Blog

Paperless Validation in Pharma: embrace the future

Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in...

Blog

GMP-compliant design of climate or stability chambers: the key to ensuring product integrity

In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of...

Blog

4 Factors Influencing the Stability of Medicinal Products

In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during...

Blog

State Of The Art Literature Review – Process and Documentation

In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the...

Blog

Digital health in pharma: revolutionizing the industry from R&D to patient care

AI, machine learning, blockchain, big data, and other buzzword technologies are making inroads into the biopharmaceutical sector, improving quality,...

Blog

Mastering Cleanroom Qualification: navigating the latest regulatory updates

Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification,...

Blog

Computerized System Validation in clinical trials: key considerations

Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.

Blog

State of the Art (SOTA) Literature Review – What, Why, When, and Who?

In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA)...

Blog

The Importance of Stability Testing in Pharmaceutical Development

In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.

Blog

Pharma 4.0: The Future of Pharmaceutical Manufacturing

Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves...

Blog

Clinical Literature Review – Common Gaps and Hurdles to Take

In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature...

Blog

EudraLex Volume 4 Annex 11: compliance checklist and future prospects

This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.

Blog

A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU

The past couple of years have borne witness to pivotal shifts in clinical trial approvals within the UK and EU. With the UK implementing the Combine Review...

Blog

Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto

On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.

Blog

The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry

The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.

Blog

MDR transition: how to plan MDR compliance for your Medical Device?

Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last...

Blog

Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!

Blog

Automated software testing for the GxP world

Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase...

Blog

Analytical Method Validation: are your analytical methods suitable for intended use?

In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.

Blog

ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway

The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and...

Blog

MHRA GMDP Symposium: key insights, trends, and best practices

QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss...

Blog

What is the Agile model in Computerized System Validation?

Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5...

Blog

EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights

The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial...

Blog

MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)

Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about...

Blog

UK’s medicines regulator announces IT roadmap

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and...

Blog

7 key areas to focus on during internal or supplier audits

Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing...

Blog

8 steps to successfully respond to non-conformities in an inspection report

Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities....

Blog

Introduction to Digital Health in Clinical Trials

Learn how digital health is transforming clinical trials. Explore the benefits and challenges of implementing digital technologies.

Blog

What is the GAMP 5 V-model in Computerized System Validation?

Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.

Blog

Essential Documents in Clinical Investigations with Medical Devices: a brief overview

This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.

Blog

UDI for software: how to mark your MDSW with a UDI?

Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read...

Blog

The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices

The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of...

Blog

Qualification of laboratory equipment: key considerations and challenges

Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.

Blog

Back to Blog Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?

Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to...

Blog

Change Control Management: how to keep your systems compliant?

In this article, you will learn a structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life...

Blog

The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Artificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and...

Blog

Medical Device development: the importance of Design Transfer and Process Validation

Bringing a Medical Device to market involves many hurdles, including design and development. In this blog post, you will learn more about the importance of...

Blog

Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma (APQR/PQR).

Blog

What is digital health? Exploring the landscape and future opportunities.

Digital health is on the rise, but what is digital health exactly? In this blog post, we'll explore the landscape, key technology pillars and future...

Blog

21 CFR Part 11 compliance checklist: does your system comply?

21 CFR Part 11 regulates the use of electronic records and signatures in pharma and medical devices. Want to comply? Read more below and download our 21 CFR...

Blog

Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy

Discover 5 reasons to engage with an experienced Contract Research Organization (CRO) specialized in medical device studies to support you in your clinical...

Blog

Finding your way through the maze of international, European, and harmonized standards for medical devices

It is important to understand how standards are written and how their references are constructed in order to properly reference them and purchase the correct...

Blog

AI and machine learning validation: strategies and examples

Want to learn more about the difference between Artificial Intelligence and Machine Learning and/or need insight into the right validation strategy for your...

Blog

What is the purpose of Periodic Reviews in CSV?

Have you validated your computerized system(s) yet? Then CSV Periodic Reviews are an important next step. Learn more about their purpose and frequency here.

Blog

The importance of high-quality gas distribution networks for critical process gases, even in the early development phase

The quality of process gases and gas distribution networks is becoming increasingly important for biotech pharmaceutical processes and ATMP sites. In this...

Blog

GAMP 5 guide 2nd edition: what’s new?

In 2022, ISPE released a new, second edition of the GAMP 5 guide. Read more about this new edition here and/or watch our webinar on demand.

Blog

Why self-inspections or internal audits are essential for your QMS

Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can...

Blog

The regulatory pathway for your custom-made medical device

Are you a manufacturer of custom-made medical devices and in need of regulatory guidance? This article summarizes key concerns to consider.

Blog

Medicine advertising in Belgium: a brief regulatory overview

In Belgium, medicine advertising is subject to legislation in order to ensure the rational use of medicines. Each firm must appoint a Responsible Person for...

Blog

PRRC under MDR and IVDR: meaning, requirements, and responsibilities

The Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Device Regulation (IVDR) (EU) 2017/746 introduced a new mandatory role in Article 15: the Person...

Blog

6 common myths about life sciences consultancy

Considering an exciting career as a life sciences consultant, but still in doubt? In this article, we debunk 6 myths about consultancy to help you decide!

Blog

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in...

Blog

Data migration in CSV: definition, purpose, and best practices

Sometimes it is necessary to perform data migration in computer systems, applications, or software. Learn more about the goal, importance and risks here.

Blog

What is decommissioning in CSV?

In CSV, decommissioning is the retirement or controlled shutdown of an IT solution or computer system that is no longer needed. Learn more about this process...

Blog

Clinical Evaluation Report (CER): a must-have for all medical device classifications

To document the clinical evaluation of your device and its output, a Clinical Evaluation Report or CER has to be compiled. Learn more about this key document,...

Blog

Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy

The Clinical Evaluation Plan, or CEP, is a crucial starting point and guide for the clinical evaluation of your medical device. Learn more about this key...

Blog

How to use electronic signatures in regulated industries?

During the pandemic, electronic signatures gained tremendous importance for companies in the regulated sector. Learn more about electronic signatures, their...

Blog

EDQM and the CEP of the future

A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the...

Blog

CAR-T cell therapy: main components, manufacturing, and prospects

CAR-T cell therapy uses genetically engineered T cells to destroy tumor cells. Learn more about the main components, manufacturing process and prospects of...

Blog

What is EUDAMED and what new requirements should medical device companies take into account?

The new medical device regulations and the associated implementation of EUDAMED are intended to give the general public access to relevant information on...

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GAMP categories for computerized systems: what are they and what are they for?

GAMP categories are very important to decide on the validation strategy of your computerized system. Learn more about all categories here.

Blog

3D printing medical devices: enabling patient-specific solutions for a better quality of care

3D printing medical devices offers unrivaled flexibility and personalization as illustrated by the case of Joe DiMeo's face and hand transplant. Curious? Be...

Blog

Dendritic (DC) cells: effective sentinels for immunotherapies

Dendritic cells play an important role in recently developed DC-based immunotherapies for the treatment of cancer, autoimmune diseases and the prevention of...

Blog

Natural Killer (NK) cells: a major breakthrough in the field of ATMPs

Natural Killer (NK) cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these...

Blog

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

In the EU, the IVDR will replace the IVDD. The compliance deadline is approaching, so act now to obtain CE marking of your IVD medical device in time.

Blog

Medical device combination products: what regulations should you apply before marketing them in the EU?

Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Guidance.

Blog

IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers

Learn more about the new risk-based approach to in-vitro diagnostic device classification under IVDR 2017/746, replacing outdated directives.

Blog

MDR impact on MDSW: what has changed from MDD?

The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more below.

Blog

Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more

Curious about the latest medical device industry trends? Learn more on wearables, AI, POC testing, IoT, and more in this blog post!

Blog

Unraveling Artificial Intelligence in Medical Devices: what do we know so far?

Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.

Blog

SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not....

Blog

5 consequences of Brexit when selling medical devices in the UK

Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical...

Blog

ATMPs: translating the expertise into a GMP process

ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.

Blog

What is a medical device? Key definitions and regulations around the world.

Is your product a medical device? Well, that depends on the markets you want to enter and their regulations. Here’s an overview to guide you.

Blog

Why Medical Device Risk Management is as complex as it is crucial

Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter,...

Blog

Clinical Trials for ATMPs: which challenges to overcome?

ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately...

Blog

10 things you should know before validating Computerized Systems

Not sure where to start when validating your computerized systems? Follow these 10 steps as a guideline.

Blog

Smart factories: How digital twins can strongly improve your ATMP manufacturing processes

In the smart factories that came with Industry 4.0, digital twins of manufacturing processes are key to improving process robustness, development lead times...

Blog

From idea to post market surveillance: the phases of the medical device lifecycle

Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of...

Blog

Why QP challenges in ATMPs are different & what you need to know

In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch...

Blog

How do you reduce the Cost of Goods, which is key to affordable ATMPs?

The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial...

Blog

What you need to know to make your medical device UDI-ready in time

UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a...

Blog

The key role of Regulatory Affairs in the pharmaceutical industry: from development to commercialization

Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. Learn more about the roles and functions that...

Regulatory update

FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)

On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities...

Regulatory update

4 key guidance documents released under the EU MDR and IVDR frameworks

Last week, the Medical Device Coordination Group (MDCG) released four key guidance documents under the EU MDR and IVDR frameworks.

Regulatory update

Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment

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...

Regulatory update

Nitrosamines Update EMA/409815/2020 Rev.22

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...

Regulatory update

New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released

On May 5th, 2025, the European Commission published a new revision of the Manufacturer Incident Report (MIR) template for reporting of serious incidents under...

Regulatory update

New UK Clinical Trials Regulations: Key Updates and What They Mean

On 11th April 2025, the UK Clinical Trial Regulation has been officially signed into law, marking the most significant update in over 20 years.

Regulatory update

New revision of Team-NB Best Practice Guidance released

On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Best Practice Guidance for the ...

Regulatory update

New revision of Team-NB Position Paper on European AI Act

On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Position Paper on the European...

Regulatory update

New Team-NB Position Paper Released on IVDR certification process

On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a new Position Paper on the certification process under ...

Regulatory update

New Revision to MDCG 2020-16 Guidenance Document Released

On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic...

Regulatory update

Fifth revision to MDCG 2019-6 Guidance document released

On February 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on...

Regulatory update

Call for expression of interest in coordinated assessment of clinical investigations/performance studies

On February 6th, 2025, the EU Member States and the European Commission announced the launch of a pilot coordinated assessment of clinical investigations under

Regulatory update

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

On 16 December 2024, the Post-market Surveillance (PMS) Statutory Instrument, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great...

Regulatory update

New MDCG Guidance documents released

On 28 January 2025, the Medical Device Coordination Group (MDCG) released its first revision of two key documents related to the European Medical Device...

Regulatory update

Expert Panel Advice on SARS-CoV-2

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...

Regulatory update

New revision to EMA Guidance documents released

On December 17th, 2024, the European Medicines Agency (EMA) released a revision of 2 guidance documents on the companion diagnostics consultation procedure to...

Regulatory update

New revisions of the Preliminary Assessment Review templates, forms and annexes

On January 10th, 2025, the Medical Device Coordination Group (MDCG) released new revisions of the Preliminary Assessment Review templates and the forms to...

Regulatory update

Second revision to MDCG 2023-3 Guidance document released

On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on...

Regulatory update

New MDCG 2020-16 Revision 3 Guidance Documents Released

On July 8th, 2024, the Medical Device Coordination Group (MDCG) released its third revision on the guidance for classification Rules for in vitro Diagnostic...

Regulatory update

MDCG 2022-3 Rev.1 released

On December 18, 2024, the Medical Device Coordination Group (MDCG) released a revision of the guidance on verification of manufactured class D IVDs by notified...

Regulatory update

Revision of MDCG 2019-13 released

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)...

Regulatory update

New MDCG 2024-16 form released

Regulatory update

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

Regulatory update

New MDCG Guidance document released

Regulatory update

New Q&A released on the gradual roll-out of EUDAMED

Regulatory update

EMA launched a new draft guideline on risk management requirements for elemental impurities in veterinary medicinal products

Regulatory update

MDCG 2023-3 Rev 1 released

Regulatory update

MDCG 2024-13 and MDCG 2022-5 Rev 1 released

Regulatory update

New Q&A on the obligation to inform in case of interruption or discontinuation of supply

Regulatory update

First Revision of MDCG 2021-25 Released

On October 16, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the “Application of MDR requirements to "legacy...

Regulatory update

MDCG 2024-12 released

On October 7th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance and templates for the assessment of Corrective and Preventive Action...

Regulatory update

MDCG 2024-11 released

On October 8th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on determining which products fall under the scope of Regulation...

Regulatory update

Newly Listed Harmonized Standards

On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union,...

Regulatory update

Revised MDCG 2021-4 Guidance Documents Released

On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the...

Regulatory update

The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs

The FDA has just released an updated version of its Control of Nitrosamine Impurities in Human Drugs Guidance, introducing crucial changes for pharmaceutical...

Regulatory update

New MDCG Guidance Documents Released

Regulatory update

Publication of Amendments to Regulation (EU) 2024/1860

On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations...

Regulatory update

MDCG: First Revision on the Guidance on Standardisation for Medical Devices

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...

Regulatory update

New Update of Appendix 1 of the Nitrosamines Guideline

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...

Regulatory update

MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies

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...

Regulatory update

Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence Repair (MDCG 2024-1-5)

On June 11th, 2024, the Medical Device Coordination Group (MDCG) released a new Device Specific Vigilance guidance (MDCG 2024-1-5 - DSVG 05) for...

Regulatory update

Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2

On May 27th, 2024, the Medical Device Coordination Group (MDCG) released a second revision on the guidance on appropriate surveillance regarding the...

Regulatory update

MDCG 2024-10: Clinical Evaluation Guidelines for Orphan Medical Devices

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).

Regulatory update

New MDCG Guidance Documents Released: Key Updates and Insights

Regulatory update

New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies

Regulatory update

Latest Update on Appendix 1 of the Nitrosamine Guidelines

Regulatory update

EU Parliament Passes Groundbreaking Proposal

Regulatory update

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

Regulatory update

New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released

Regulatory update

New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices

Regulatory update

New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies

Regulatory update

New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)

Regulatory update

New MDCG Guidance Released: Device-Specific Vigilance Document

Regulatory update

Newly Published Harmonized Standards for MDR and IVDR Compliance

Commission Implementing Decision (EU) 2024/815 as regards harmonised standards for “medical gloves for single use, biological evaluation of medical devices,...

Regulatory update

EU Council Endorses Proposal to Amend IVDR and MDR Regulations

Regulatory update

Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions

Regulatory update

Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers

Regulatory update

New EMA FAQ on medicinal products development and assessment involving a CDx

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Knowledge center

Clinical Evaluation for Medical Devices under MDR

21 CFR Part 11 compliance checklist

Achieving laboratory compliance

A Complete Guide to Computer System Validation

Analytical Method Validation

Annual Product Quality Review in Pharma

ISO 13485:2016 - Compliance Checklist

Clinical evidence for In Vitro Diagnostics under IVDR

Clinical investigations under MDR: key insights and practical experiences

Digital Health - Exploring the landscape and future opportunities

Ensuring compliance and quality in Pharmacovigilance

EUDRALEX Volume 4 Annex 11 Compliance Checklist

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

GAMP categories for computerized systems: what are they and what are they for?

ICH Stability Studies on Pharmaceuticals

Innovations in ATMP: state of the industry in 2024

IVDR extension: what does this mean for you?

Mobile health on the rise: exploring the regulatory landscape for reimbursement

New GMP Facility Qualification: set-up, process and best practices

Organic and mutagenic impurities in pharma

The pathway from idea to patient under MDR

Regulatory Affairs for Pharma and Biotech

Standards and regulations for software used in Medical Devices

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

The One-Vigilance strategic roadmap to corporate excellence

EU GMP: How to import your products into the EU?

Ensuring a smooth MDR transition for Oystershell's medical devices

Ensuring pharmaceutical production quality: cleaning validation for government agency

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Help BioLizard build their Quality Management System

Helping Abraca BioSystems to obtain ISO 13485 certification

Helping Relu to comply with changing regulations

Optimizing pharmacovigilance for a biotechnology leader

Patient Support Program (PSP)

Quickly bringing a new COVID-19 medical device to market

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

Supporting Oncomfort in developing and certifying their ISO 13485 QMS

The journey toward IVDR compliance for the LVOne device

3D Printing in the Healthcare World

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Drug-Device Combination Products and Article 117

How to manage mandatory communication of Toxicological Risks?

IVDR Extension Explained: Tips & Strategies

Mastering Clinical Performance Studies under IVDR

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

From Requirements to Code: a unified MDSW development cycle that covers all requirements

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Technical Documentation Essentials for Medical Device Software

Post-Market Surveillance Requirements for Medical Devices and IVDs

The Basic Concepts of the QbD Methodology

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

CE Mark Renewal for bioXtra Products: A Success Story

Medical Device Regulation (MDR) Checklist

How to keep computerized systems in the operational phase

Scalable MSAT validation support for seamless compliance & efficiency

Restoring manufacturing timelines through expert deviation management

Guiding a global biotech company through ATMP facility qualification

Enhancing data integrity & aseptic manufacturing compliance

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Fast-Tracked Site Qualification for Clinical Trial Submission

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Environmental Risk Assessment (ERA) in Drug Products: Understanding the New EMA Guideline Updates

Outsourced QA: Benefits, Risks, and Long-Term Impact

IVDR Compliance for Large-Panel Next-Generation Sequencing (NGS) Devices: A Strategic Guide

Life Sciences Digitization: Your Compliance Roadmap

The Triangle Dilemma of Quality, Cost & Time in GMP Laboratories

Pharmacovigilance Is a Shared Responsibility: Why Adverse Events Reporting Matters More Than Ever

Drowning in APR/PQR Work? Here’s How to Lighten the Load.

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader