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.

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.

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.

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 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 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

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

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.

Blog

How to keep computerized systems in the operational phase?

Computerized systems play a crucial role in the life sciences, as these systems are used in daily activities such as data management, key processes, and...

Blog

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

In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneurship and SMEs (europa.eu)) have gained a lot of...

Blog

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

In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no different for computerized systems. It’s not always that...

Blog

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

What is a medical device? This crucial question often arises when bringing medical devices to market. Determining whether your product qualifies as a...

Blog

SCADA Automation in Pharma: Boosting Efficiency and Compliance

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the precise production of life-saving...

Blog

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

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically validated digital technologies to enhance health and...

Blog

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

In the dynamic landscape of medical device regulations, the recent proposal by the European Commission to extend the transitional...

Blog

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Blog

Starting a new job in Corona times: this is how Katrien experienced it at QbD

Katrien Coppens has joined our QbD back office team and is mainly responsible for finance topics. Her onboarding is an adventure she won’t easily forget. “Not...

Blog

State Of The Art Literature Review – Process and Documentation

A comprehensive, objective, and thorough systematic literature review to describe the general State of the Art and identify all relevant clinical safety,...

Blog

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

What’s the Goal of a Periodic Validation Review?

Blog

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

Germany has always been renowned for its meticulous attention to detail, often described by the term ‘Deutsche Gründlichkeit’. It’s no wonder then,...

Blog

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

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of officially approved information for Healthcare...

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 adopted the proposal to extend the transitional period for legacy devices (i.e. those covered by a certificate or...

Blog

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

Friability and disintegration testing are often overlooked during pharmaceutical development or testing; however, they play a certain role in...

Blog

Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often occur due to sequential activities, such as...

Blog

Elevate Pharma Imports with EU GMP Annexes 16 and 21

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared responsibility that transcends borders. The...

Blog

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

The safety of medicines is a fundamental concern in the field of public health, and in Europe, pharmacovigilance plays a crucial role in ensuring...

Blog

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

In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a significant transition from the previous In...

Blog

What to expect when being inspected?

In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance” we talked about the steps to take after the...

Blog

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

In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is paramount to ensure IVDs are...

Blog

Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active substances in animals during the pre-clinical...

Blog

Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Elemental impurities might not be the first thing you think of when it comes to drug safety, but they are crucial to understand. These impurities ...

Blog

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

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these advances could have on the environment. The...

Blog

Declaration of Equivalence for Medical Devices under the MDR

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Medical Device Directive (MDD) or the Active...

Blog

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

Introduction Did you know that the precision of analytical methods directly influences the safety and efficacy of pharmaceutical products? Understanding...

Blog

How to create a GMP-Compliant Stability Protocol?

Introduction to Stability Testing in Pharmaceuticals Stability testing is a regulatory and scientific mandate to guarantee that pharmaceutical...

Blog

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

In healthcare, safeguarding patient safety and upholding the integrity of pharmaceutical interventions are paramount. Enter pharmacovigilance (PV), a...

Blog

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

In the complex and highly regulated world of pharmaceuticals, thesynergy between Quality and Regulatory Affairsis not just crucial, it’s indispensable....

Blog

Continuous manufacturing in the pharmaceutical industry: enhancing drug production

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch...

Blog

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

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) following Brexit was introducing a...

Blog

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

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is often mistaken to be the same as Software As Medical...

Blog

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

Conformity assessments for CE approval As indicated on the website of the European Commission, a medical device can only be...

Blog

Qualifying a new GMP facility: from pitfalls to best practices

In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to stringent quality control and precision....

Blog

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

In an era of increasing globalization, the pharmaceutical landscape is undergoing significant changes. This blog post offers a structured insight...

Blog

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

In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug development, manufacturing, quality control, and...

Blog

Understanding plasmids: small molecules with big implications

Plasmids are used in various research and biotechnology applications, such as gene therapy, vaccine development, and recombinant protein production.

Blog

Paperless Validation in Pharma: embrace the future

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activities, and computerized systems to streamline their...

Blog

The regulatory pathway for your custom-made medical device

Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU) 2017/745. The MDR mentions “other than...

Blog

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

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, providing crucial insights into the durability and...

Blog

4 Factors Influencing the Stability of Medicinal Products

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safety throughout their shelf life. Numerous factors come...

Blog

Mastering Cleanroom Qualification: navigating the latest regulatory updates

In 2022, significant updates were made to the main standards that impact the qualification of cleanrooms. These updates include: EU GMP...

Blog

Computerized System Validation in clinical trials: key considerations

Computerized systems have become an integral part of clinical research, from data collection to analysis and reporting. However, ensuring the accuracy,...

Blog

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

State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical device, which is defined as an ongoing collection,...

Blog

Pharma 4.0: The Future of Pharmaceutical Manufacturing

Industry 4.0 refers to the fourth industrial revolution, and within the pharmaceutical industry, there is a specific term called Pharma 4.0. It involves...

Blog

The Importance of Stability Testing in Pharmaceutical Development

Stability testing plays a crucial role in the development of medicinal products, ensuring that they maintain their quality, safety, and efficacy...

Blog

EudraLex Volume 4 Annex 11: compliance checklist and future prospects

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the European Union‘s pharmaceutical industry. It...

Blog

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

In June 2022, concerns were expressed that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) would...

Blog

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

Nowadays, regulations on medical devices and medicinal products have very strict expectations on documents outlining the benefits and performance and...

Blog

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

What is Analytical Method Validation? Analytical method validation is a critical process in the pharmaceutical, biotechnology, and food industries...

Blog

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

In order to give patients quicker access to cutting-edge treatments and therapies, the UK government introduced a pathway in 2021 called “Innovative...

Blog

What is the Agile model in Computerized System Validation?

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation activities can use either the V-model or the Agile model....

Blog

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

EU GMP Annex 1’s revision – the 2022 update to ‘ Manufacture of Sterile Medicinal Products‘ – aimed to eliminate ambiguities and inconsistencies while...

Blog

7 key areas to focus on during internal or supplier audits

Regulatory agencies require internal and supplier auditsin the pharmaceutical and medical device industry to ensure products are safe and effective....

Blog

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

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s compliance with regulatory requirements to ensure...

Blog

Introduction to Digital Health in Clinical Trials

Digital technology is transforming the way clinical trials are conducted, offering new opportunities to improve patient experience, data quality, and trial...

Blog

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

Using software for your life sciences operations requires high integrity and security in the data processing. Your computer systems must be designed to...

Blog

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

Are you performing clinical research with medical devices? In this blog post, we provide a brief overview of essential documents required during a...

Blog

Qualification of laboratory equipment: key considerations and challenges

The introduction of a new product into your company’s portfolio may require expanding your existing laboratories or even building a new laboratory to...

Blog

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

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefly explains what a UDI is and how to implement it on...

Blog

Change Control Management: how to keep your systems compliant?

Change control management is an essential part of any quality assurance system. It enables us to maintain control of the validated status and always be in...

Blog

The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the landscape of our daily lives, just think about...

Blog

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

Bringing a Medical Device to market involves many hurdles, including medical device design and medical device development. While the design and development...

Blog

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

Current regulations require written documentation for all existing products in the company; this documentation is known as the A nnual Product Quality...

Blog

AI and machine learning validation: strategies and examples

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have been the buzzwords of the past year. Every...

Blog

What is the purpose of Periodic Reviews in CSV?

Current regulations require that manufacturing processes in the pharmaceutical industry be validated , and once validated, they must be continuously...

Blog

GAMP 5 guide 2nd edition: what’s new?

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been widely used in life science industries for validating...

Blog

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

Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 Quality Management System must conduct self-inspections...

Blog

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

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance or ‘PRRC’ is a mandatory role introduced by the ...

Blog

New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

Current EU regulatory framework for MIA holders In recent years, medicinal products for the EU market are increasingly manufactured outside the EU ...

Blog

What is decommissioning in CSV?

Changes in business needs or technology are inevitable. They often lead to the retirement or “decommissioning” of computerized systems. ERP systems, for...

Blog

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

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, and analysis of clinical data related to your device –...

Blog

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

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in the EU. For planning and documenting...

Blog

EDQM and the CEP of the future

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization (MA) from the respective licensing authority. In...

Blog

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

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 years, exemplifies the innovative strides made in areas...

Blog

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

New to validating computerized systems? If so, it might be difficult to get started on this type of validation. Why? Because, even if you have experience...

Blog

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

Additive manufacturing, particularly 3D printing, has attracted strong attention of the medical devices and medical community at large over the past...

Blog

Cell therapy as an ATMP: introduction, definition, and subtypes

Cell therapy, a key component of Advanced Therapy Medicinal Products (ATMPs), represents a groundbreaking approach in modern medicine. Defined by the EMA...

Blog

10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven

Jeroen and Bart at Bart’s bachelor party If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you...

Blog

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

Natural Killer cells or NK cells are large lymphocytes (white blood cells) that play a crucial role in our innate immune system. The innate immune system,...

Blog

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

In recent years, more and more medicinal products (MP) are used in conjunction with a medical device (MD). These are called “ combination products”....

Blog

MDR impact on MDSW: what has changed from MDD?

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next...

Blog

QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences

QbD Academy in a nutshell What is the QbD Academy? The QbD Academy is a young graduates program that combines working and learning...

Blog

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

Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support,...

Blog

10 things you should know before validating Computerized Systems

Blog

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

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug development: a lengthy, complex, and extremely costly but...

Blog

Stay up to date with the latest in life sciences

One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by...

Blog

Quality by design methodology for the pharmaceutical industry

How to guarantee medicine quality and patient safety To explain the quality by design methodology, it’s important to first pay attention to how the quality...

Blog

EU GMP Annex I: Are we ready for the challenges posed after its revision?

After months of revision and many questions raised, it now appears that the time is coming to implement the new requirements contained in the revision of...

Blog

Antleron & QbD team up to create a landslide in healthcare

A whole new era in healthcare is coming closer every day. Thanks to the crossover of 3D printing and biology, medical solutions will be personalized like...

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-definedIntended Purpose. This statement...

Regulatory update

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Regulatory update

MDCG 2022-3 Rev.1 released

Notified bodies are required to verify product batches of class D IVDs. Therefore, manufacturers should forward to notified bodies the reports on tests carried...

Regulatory update

Revision of MDCG 2019-13 released

MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

Regulatory update

New MDCG 2024-16 form released

On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer Information Form on Interruption or Discontinuation of Supply of...

Regulatory update

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

On November 26th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the implementation of the Master UDI-DI solution for contact...

Regulatory update

New MDCG Guidance document released

On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the publication of the clinical investigation reports and their...

Regulatory update

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

On November 21st, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the gradual roll-out of EUDAMED. This document provides a Q&A related to...

Regulatory update

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

Last October, the EMA launched a new draft for public consultation on the risk assessment of elemental impurities in veterinary products, which will replace...

Regulatory update

MDCG 2023-3 Rev 1 released

On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision (MDCG 2023-3 Rev 1) of the questions and Answers on vigilance...

Regulatory update

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

On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO)...

Regulatory update

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

On October 30th, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the obligation to inform in case of interruption or discontinuation of...

Regulatory update

First Revision of MDCG 2021-25 Released

Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021This guidance outlines how MDR requirements relate...

Regulatory update

MDCG 2024-12 released

Regulatory update

MDCG 2024-11 released

Regulatory update

Newly Listed Harmonized Standards

EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) is now a harmonised standard under both the...

Regulatory update

Revised MDCG 2021-4 Guidance Documents Released

Regulatory update

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

What’s new?

Regulatory update

New MDCG Guidance Documents Released

MDCG revises Q&A on importers, distributors' requirements (MDCG 2021-27 Revision 1), EU Regulations 2017/745 & 2017/746.

Regulatory update

Publication of Amendments to Regulation (EU) 2024/1860

Regulation (EU) 2024/1860 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and...

Regulatory update

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

MDCG 2021-05 Revision 1: Guidance on standardization for medical devices The scope of this document is to provide guidance on different aspects related to...

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

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

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

On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. On May 15th, 2024, the Medical Device...

Regulatory update

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

On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body survey on certifications and applications under the MDR and...

Regulatory update

Latest Update on Appendix 1 of the Nitrosamine Guidelines

On 01/05/2024, the European Medicines Agency (EMA) rolled out an update to Appendix 1 (EMA/154403/2024 /Rev. 4) of the Nitrosamines Guideline. In this Appendix...

Regulatory update

EU Parliament Passes Groundbreaking Proposal

On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations...

Regulatory update

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and...

Regulatory update

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

On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro...

Regulatory update

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

On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical...

Regulatory update

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

New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices. On March 12th,...

Regulatory update

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

The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established...

Regulatory update

New MDCG Guidance Released: Device-Specific Vigilance Document

The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide...

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

The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR.

Regulatory update

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

EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.

Regulatory update

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

EU Commission published MDR and IVDR language requirement tables for medical device manufacturers, aiding compliance with linguistic regulations across Member...

Regulatory update

New EMA FAQ on the Development and Assessment of Medicinal Products Involving Companion Diagnostics (CDx)w EMA FAQ on medicinal products development and assessment involving a CDx

EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation. ...

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