Smart factories: How digital twins can strongly improve your ATMP manufacturing processes
Smart factories: How digital twins can strongly improve your ATMP manufacturing processes
Sunday, 25 April 2021
Evan Claes, ATMP Bioprocess & Data Architect & Tommy Heck, Digital Twin and Modeling Architect at Antleron
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In the smart factories that came with Industry 4.0, digital twins of manufacturing processes are key to improving process robustness, development lead times and ultimately reducing costs. In this blog Evan Claes and Tommy Heck from our partner Antleron explain how digital twins work and why they are so vital, especially to ATMP manufacturing.
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Smart factories: How digital twins can strongly improve your ATMP manufacturing processes | QbD Group
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Industry 4.0 is currently revolutionizing the design, manufacturing and services of healthcare applications. It includes the automation and digitization of manufacturing techniques, the acquisition and analysis of process data and the communication between machines. Together, these innovations result in self-managed processes that turn traditional practices and manufacturing into so called smart factories.
What is a digital twin?
An important aspect of these smart factories are digital twins. A digital twin is commonly described as a virtual replica of a physical product or process. It is a real–time computermodel that can be used to predict process outcomes, optimize a process design or monitor and control the production process. The digital twin receives real-time sensor data of the process and uses historical data orfoundational assumptions (e.g. physical laws) to simulate the process evolution.
A digital twin can be used to predict process outcomes, optimize a process design or monitor and control the production process.
In this way, both the efficiency and quality of the process can be increased, which also generates an important economic cost-benefit. This is especially important for ATMPs, whose manufacturing processes are typically very complex and often suffer from large variability.
The computer models that are used in digital twins can be subdivided into so-called mechanistic and data-driven models. Both model types have their own strengths and weaknesses, and some digital twins may primarily or even exclusively use one or the other, depending on the application. However, the most successful digital twins typically use a combination of both.
But first, let’s take a closer look at the differences between these models.
Mechanistic model: process insight
Mechanistic models are directly based on the underlying scientific laws of the process. The biggest advantage of mechanistic models is that they can provide insight into the process because their parameters are based on the underlying physics. Therefore, a mechanistic model can also be easily adapted to changes. However, mechanistic models, in general, have a high development cost, their parameters can be difficult to validate, and they can require large computing resources, which might hamper real-time computations.
Data-driven model: speed and efficiency
The data-driven approach uses collected process data together with machine learning models to build (part of) a digital twin. In contrast to a mechanistic model, a data-driven model does not rely on physical and biological knowledge of the system, but uses process data to build a mathematical model that can simulate the process. They are sometimes called ‘black-box’ models, as they provide little to no new insight into the underlying dynamics of the process because the models only simulate patterns they learn from data but are not based on physical or biological principles.
However, a major advantage of these models is that their development is fast and efficient (provided that sufficient data is available. They can run in real-time with the process and their validation is relatively straightforward. The correlations they provide can for example be used to monitor the process Critical Quality Attributes (CQAs) non-destructively and in real-time, an application which is also known as soft sensing.
Hybrid digital twin computer models offer an appealing trade-off between development speed and process insight.
Hybrid approach: best of both worlds
In between these two extremes lies the hybrid approach that attempts to combine the best of both worlds. The fundamental idea behind this approach is to use the complementarity of the two opposing methodologies: a mechanistic process model can be used to model the part of the process about which established physical knowledge is available (e.g. fluid flow or nutrient distribution), while a data-based model is used to model the part of the process which cannot be modeled mechanistically because of the complexity or lack of available knowledge (e.g. cell growth kinetics).
Such models offer an appealing trade-off between development speed and process insight. Additionally, they can outperform mechanistic and data-based models with regard to predictive power and applicability.
Key role in process management
Digital twins play a central role in the digitization and automation of manufacturing strategies, particularly for the field of advanced therapy medicinal products (ATMPs), which are medicinal products based on cell, gene and tissue engineering processes. If successful, digital twins can be used to fast-track process development by allowing scientists and engineers to run simulation experiments as part of the process development. These kinds of experiments can be carried out much faster and at a much lower cost than typical ‘wet lab’ experiments, because the latter comes with long process times and high raw material costs.
Without a digital twin, it’s impossible to achieve the required high level of non-invasive process monitoring and control.
Once the process is deployed in manufacturing, digital twins play a key role in process management by allowing to monitor the full process at every time point, and thus increasing the process robustness and manufacturing reliability through increased process control.
Essential to personalized manufacturing
For ATMPs however, bear in mind that the process needs to be equipped with a flexible control strategy in order to ensure consistent product quality in the face of significant raw material variability, in particular for autologous processes. On top of this, the industry is currently moving towards personalized manufacturing in which the end product is tailored to individual patient demands, further stressing the need for a high level of non-invasive process monitoring and control. Without the power of a digital twin, this is impossible to do.
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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.
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.
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
Organic and mutagenic impurities in pharma
Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.
Whitepaper
Organic and mutagenic impurities in pharma
Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.
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.
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.
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.
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
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
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
Analytical Method Validation
In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.
Whitepaper
Analytical Method Validation
In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.
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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.
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.
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.
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
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.
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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
IVDR Extension Explained: Tips & Strategies
Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.
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
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.
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
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
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
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
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).
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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
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
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.
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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.
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.
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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
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
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 expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
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 expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
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
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.
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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.
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.
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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
Helping Relu to comply with changing regulations
QbD Group supported software company Relu with their expertise to comply with changing regulations.
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 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.
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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
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
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
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.
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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
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.
Resources
Webinar
AI in Life Sciences
Join our webinar with delaware on implementing compliant AI in life sciences. Learn best practices and avoid pitfalls in GxP environments from industry experts. Register now.
Webinar
AI in Life Sciences
Join our webinar with delaware on implementing compliant AI in life sciences. Learn best practices and avoid pitfalls in GxP environments from industry experts. Register now.
Webinar
From Strategy to First-in-Human: A Practical Roadmap for Biotech Development
Join our webinar to learn how to navigate nitrosamine risks and streamline your biotech development from early planning to first-in-human trials. Register now for expert insights.
Webinar
From Strategy to First-in-Human: A Practical Roadmap for Biotech Development
Join our webinar to learn how to navigate nitrosamine risks and streamline your biotech development from early planning to first-in-human trials. Register now for expert insights.
Webinar
Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations
Manage the risk of nitrosamines in the pharmaceutical industry. Join our webinar and learn about regulation and risk analysis from experts.
Webinar
Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations
Manage the risk of nitrosamines in the pharmaceutical industry. Join our webinar and learn about regulation and risk analysis from experts.
Webinar
From R&D to market IP and regulatory strategy across the product life cycle
Join this Biovia x Gevers x QbD Group webinar to explore product life cycle strategies, focusing on R&D, regulatory alignment, and Quality by Design insights for life sciences professionals.
Webinar
From R&D to market IP and regulatory strategy across the product life cycle
Join this Biovia x Gevers x QbD Group webinar to explore product life cycle strategies, focusing on R&D, regulatory alignment, and Quality by Design insights for life sciences professionals.
Case study
GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software
Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.
Case study
GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software
Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.
Webinar
Fast GxP compliance: Accelerating Digital Transformation in Life Sciences
QbD Group and delaware are combining their expertise to deliver a powerful webinar on how to implement and validate SAP efficiently, without compromising on compliance. You don't want to miss it!
Webinar
Fast GxP compliance: Accelerating Digital Transformation in Life Sciences
QbD Group and delaware are combining their expertise to deliver a powerful webinar on how to implement and validate SAP efficiently, without compromising on compliance. You don't want to miss it!
Whitepaper
Optimizing APR–PQR for Compliance and Efficiency
Discover practical ways to streamline APR/PQR, reduce QA workload, and improve compliance through better data, templates, digital tools, and external support.
Whitepaper
Optimizing APR–PQR for Compliance and Efficiency
Discover practical ways to streamline APR/PQR, reduce QA workload, and improve compliance through better data, templates, digital tools, and external support.
Whitepaper
Cleaning Validation in Pharma
Learn how risk-based cleaning validation, HBELs, and modern analytical methods help ensure compliant, contamination-free pharmaceutical manufacturing. Download the whitepaper.
Whitepaper
Cleaning Validation in Pharma
Learn how risk-based cleaning validation, HBELs, and modern analytical methods help ensure compliant, contamination-free pharmaceutical manufacturing. Download the whitepaper.
Webinar
Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs
This webinar on demand will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Webinar
Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs
This webinar on demand will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Whitepaper
The Essential CSV & Digitalization FAQ for Life Sciences Companies
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.
Whitepaper
The Essential CSV & Digitalization FAQ for Life Sciences Companies
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.
Whitepaper
Digitalization in the Pharmaceutical Industry: And How to Stay Compliant
Digitalization and Pharma 4.0 drive digital transformation. Explore the role of CSV in pharma's digital journey.
Whitepaper
Digitalization in the Pharmaceutical Industry: And How to Stay Compliant
Digitalization and Pharma 4.0 drive digital transformation. Explore the role of CSV in pharma's digital journey.
Webinar
PMS & PMCF Compliance for Medical Devices Under EU MDR
Gain practical insights on PMS & PMCF compliance for medical devices under EU MDR. Watch our webinars on demand.
Webinar
PMS & PMCF Compliance for Medical Devices Under EU MDR
Gain practical insights on PMS & PMCF compliance for medical devices under EU MDR. Watch our webinars on demand.
Case study
Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access
Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.
Case study
Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access
Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.
Case study
Agile Validation Support for a Global Life Sciences Organization
Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.
Case study
Building a Unified QMS for a Non-Profit Lab Organization
A non-profit lab organization unified its quality management processes by implementing a validated SAAS QMS, enhancing compliance and efficiency across departments.
Case study
Agile Validation Support for a Global Life Sciences Organization
Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.
Case study
Building a Unified QMS for a Non-Profit Lab Organization
A non-profit lab organization unified its quality management processes by implementing a validated SAAS QMS, enhancing compliance and efficiency across departments.
Case study
Faster Market Entry Through Integrated IVDR and WHO Strategy
Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.
Case study
Faster Market Entry Through Integrated IVDR and WHO Strategy
Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.
Case study
Multiplex STI PCR Test: Supporting a Smooth IVDR Journey
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.
Case study
Multiplex STI PCR Test: Supporting a Smooth IVDR Journey
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.
Whitepaper
Audit Trail Review in GxP Environments
Learn how to implement a risk-based Audit Trail review strategy to enhance software compliance in GxP environments.
Whitepaper
Audit Trail Review in GxP Environments
Learn how to implement a risk-based Audit Trail review strategy to enhance software compliance in GxP environments.
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.
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.
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.
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.
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.
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.
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 approaches to study design and risk assessment across the product lifecycle.
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 approaches to study design and risk assessment across the product lifecycle.
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
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
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
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
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
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.
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
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.
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.
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 pharmaceutical products.
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 pharmaceutical products.
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.
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
Supporting Market Access to Essential Medicines in Europe
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.
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.
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.
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
Supporting Market Access to Essential Medicines in Europe
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.
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.
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.
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.
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!
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!
Whitepaper
Medical Device Regulation (MDR) Checklist
Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.
Whitepaper
Medical Device Regulation (MDR) Checklist
Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.
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
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.
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.
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.
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
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
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
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
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.
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
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.
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
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.
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
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.
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
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
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
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
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
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.
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
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.
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 results achieved.
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 results achieved.
Webinar
Technical Documentation Essentials for Medical Device Software
Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.
Webinar
Technical Documentation Essentials for Medical Device Software
Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.
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
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.
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.
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
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.
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.
Webinar
The Basic Concepts of the QbD Methodology
Learn the basics of QbD methodology with industry experts in this on-demand webinar.
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
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.
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.
Webinar
The Basic Concepts of the QbD Methodology
Learn the basics of QbD methodology with industry experts in this on-demand webinar.
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
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.
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.
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.
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.
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.
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
Achieving laboratory compliance
This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.
Whitepaper
Achieving laboratory compliance
This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.
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
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
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
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
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
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!
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
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.
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
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.
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
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.
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.
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.
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.
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
Organic and mutagenic impurities in pharma
Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.
Whitepaper
Organic and mutagenic impurities in pharma
Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.
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.
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.
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.
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
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
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
Analytical Method Validation
In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.
Whitepaper
Analytical Method Validation
In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.
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.
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.
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.
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
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.
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
IVDR Extension Explained: Tips & Strategies
Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.
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
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.
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
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
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
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
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
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
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
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
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.
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.
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
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
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 expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
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 expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
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
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.
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.
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
Helping Relu to comply with changing regulations
QbD Group supported software company Relu with their expertise to comply with changing regulations.
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
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 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
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
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
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
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
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
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.
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