Blog | QbD Group

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

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

In this blog entry, we explain the difference between ISO and IEC standards, what harmonized standards are, and how to use the appropriate standard references in your technical documentation. We also give you a hint on how to make sure you have identified all applicable standards for your products.

AI and machine learning validation: strategies and examples

Want to learn more about the difference between Artificial Intelligence and Machine Learning and/or need insight into the right validation strategy for your AI- or ML-based systems and products? Read more here.

What is the purpose of Periodic Reviews in CSV?

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

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

The quality of process gases and gas distribution networks is becoming increasingly important for biotech pharmaceutical processes and ATMP sites. In this blog, we highlight the importance of a qualified process gas and distribution network, even at an early stage of development.

New edition of the GAMP 5 guide ‘A Risk-Based Approach to compliant GxP Computerized Systems’ expected in 2022

The ISPE announced in February that a new, second edition of the GAMP 5 guide will be released in July 2022. Read more about this new edition here and join our upcoming webinar!

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

Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.

The regulatory pathway for your custom-made medical device

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

Medicine advertising in Belgium: a brief regulatory overview

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

PRRC | Person Responsible for Regulatory Compliance

Person Responsible for Regulatory Compliance or ‘PRRC’: meaning, requirements, and responsibilities

The Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Device Regulation (IVDR) (EU) 2017/746 introduced a new mandatory role in Article 15: the Person Responsible for Regulatory Compliance or ‘PRRC’. Wondering what the meaning of the PRRC-role is and where you can find the right person? Then read on!

6 common myths about life sciences consultancy

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

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.

Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy

At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.

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

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

Meet QbD Ambassador and Device Compliance Specialist Catarina Cruz

At QbD, we value the opinion of our employees. Therefore, QbD’s Board of Ambassadors was formed to represent the voice of all QbD’ers, across the QbD Group and across all borders. Catarina Cruz has been elected as one of our Ambassadors for 2022. Congratulations! As an Ambassador, Catarina loves to share how she experiences working at QbD. Want to find out more about her #QbDream job? Make sure to read the interview below.

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

On August 21, 2022, the new GMP Annex 21 will enter into force. This Annex contains the GMP requirements for MIA holders when importing medicinal products from outside the EU/EEA. Learn more here.

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

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

How to use electronic signatures in regulated industries?

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

Clinical Evaluation Plan (CEP) roadmap for your clinical evaluation strategy

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

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

What is decommissioning in CSV?

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

10Y Steven Vinkx at QbD: from Project Engineer to Head of PMO

Steven Vinkx has been working for QbD for 10 years now, and counting. Congratulations! Curious about his career and insights? Then be sure to read this interview!

Clinical evaluation for medical devices under MDR: a brief guide

Clinical evaluation of medical devices is critical to obtaining and maintaining marketing approval in the EU. Learn more about clinical evaluation here.

EDQM and the CEP of the future

A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.

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

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

10Y Dominiek Rossillion at QbD: from Quality Engineer to Business Development Manager

Dominiek Rossillion has been working for QbD for 10 years now, and counting! Our heartiest congratulations! Curious about Dominiek’s career and insights? Then be sure to read this interview!

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

The new medical device regulations and the associated implementation of EUDAMED are intended to give the general public access to relevant information on medical devices, ensuring greater transparency. However, EUDAMED also brings new requirements for market participants throughout the life cycle of medical devices. Read more about them here!

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

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

10 questions for ‘10Y anniversary girl’ Katrien Janssens

10 years! That’s how long Katrien Janssens has been working at QbD now. Congratulations! Curious to know how Katrien has experienced the past decade at QbD? During a brief interview, we asked her 10 quick questions: one for each year she has worked with us!

3D Technologies Support World’s First Successful Double Hand and Face Transplant Materialise

3D printing enables patient-specific medical devices for a better quality of care

3D printing offers unrivaled flexibility and personalization in medical devices as illustrated by the case of Joe DiMeo’s face and hand transplant. Curious? Be sure to read on!

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

Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. Learn more about the roles and functions that RA teams can provide in the lifecycle management of your pharmaceutical product.

Quality Control challenges in closed systems: implementing AI as an in-process control

Sampling, testing, and preserving your medicinal product in closed systems often present difficult Quality Control challenges. As part of the solution, various AI-based in-process controls can be used. Discover them here!

A Day in the Life of MD Specialist Steven

A Day in the Life of a QbD MD Specialist

Medical devices are one of QbD’s main areas of expertise. We support you from concept to launch in the full life cycle. Wondering what a day in the life of a QbD MD Specialist looks like? Let’s take a look behind the scenes!

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

Cell therapy includes various ATMPs to fight tumors or restore the physiological status of damaged tissue. Explore them here.

10 Questions for 10Y birthday boy Jeroen Verhoeven

10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven

If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you that the 10Y anniversary of an employee is an EXTRA big deal to us. After QbD founder Bart (obviously), Jeroen Verhoeven is the very first employee to reach that landmark.

In order to give this news the attention it deserves, we fired 10 questions at Jeroen, one for each year he’s been with us!

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