Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
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Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSAÂ
In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.
Understanding plasmids: small molecules with big implications
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses: the use for cancer immunotherapy
Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks, and specific biosafety requirements to be considered for oncolytic viruses.
Paperless Validation in Pharma: embrace the future
Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in the digital era.
GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of pharmaceutical products.
Regulatory guidelines for stability testing: a brief overview
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
State Of The Art Literature Review – Process and Documentation
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
4 Factors Influencing the Stability of Medicinal Products
In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during their storage.
The digital health revolution in pharma
AI, machine learning, blockchain, big data, and other buzzword technologies are making inroads into the biopharmaceutical sector, improving quality, traceability, and efficiency. Read more about how digital health is changing pharma here.
Mastering Cleanroom Qualification: navigating the latest regulatory updatesÂ
Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification, requalification, monitoring) with a focus on risk assessment.
Computerized System Validation in clinical trials: key considerations
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
State of the Art (SOTA) Literature Review – What, Why, When, and Who?  Â
In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.
The Importance of Stability Testing in Pharmaceutical Development
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Pharma 4.0: The Future of Pharmaceutical Manufacturing
Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves efficiency, quality and patient safety.
Clinical Literature Review – Common Gaps and Hurdles to Take
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).
EudraLex Volume 4 Annex 11: compliance checklist and future prospects
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
How to keep computerized systems in the operational phase?
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Automated software testing for the GxP world
Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.
Analytical Method Validation: are your analytical methods suitable for intended use?
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
MDR transition: how to plan MDR compliance for your Medical Device?
Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway
The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes. Learn more about ILAP in this blog post.
MHRA GMDP Symposium: key insights, trends, and best practices
QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss the latest trends and developments. Discover our insights here.
What is the Agile model in Computerized System Validation?Â
Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5 framework for agile development.
EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights
The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial insights several months after the revision.
MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)Â
Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about the contents and requirements of the annex.
UK’s medicines regulator announces IT roadmap
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.
7 key areas to focus on during internal or supplier auditsÂ
Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.
8 steps to successfully respond to non-conformities in an inspection report Â
Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities. Failure to act can have crippling consequences.
Celebrating International Women’s Day with power lady Elly De Bruyn, CHRO at the QbD Group
In celebration of International Women’s Day, we sat down with Elly De Bruyn, Chief Human Resources Officer (CHRO) at the QbD Group, to talk about her experiences and views as a power lady in the life sciences industry.
Introduction to Digital Health in Clinical Trials
Learn how digital health is transforming clinical trials. Explore the benefits and challenges of implementing digital technologies.
What is the GAMP 5 V-model in Computerized System Validation?Â
Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.
Essential Documents in Clinical Investigations with Medical Devices: a brief overview
This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.
The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical DevicesÂ
The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.
Qualification of laboratory equipment: key considerations and challenges
Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.
UDI for software: how to mark your MDSW with a UDI?
Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read the answer in this article!
Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to find out.
Medical Device and IVD industry trends for 2023
In 2023, the IVD industry will continue to dominate the medical technology market due to rising demand for early diagnosis, treatment and point-of-care testing. Product trends include the accelerated consumerization of diagnostics, the rise of telemedicine and digital health, the growth of devices enabling personalized medicine and the emergence of AI and robotics-powered medical devices. Medical device manufacturing will undergo changes in the computerized system validation process due to the increased focus on critical thinking by GAMP5 and FDA.
Change Control Management: how to keep your systems compliant?
In this article, you will learn a structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life cycle.
Helping others is what brings the QbD Group joy every day
December is often symbolized as the ‘Month of Giving’ as it revolves around giving something back to society, helping others and spreading joy. Supporting good causes is one way we put our company value ‘joy’ into practice at the QbD Group. Let’s highlight a few of them!
The Advent of Artificial Intelligence and Machine Learning in Medical Devices
Artificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and regulatory framework here.
Annual Product Quality Review (APQR) in Pharma: importance, benefits & challenges
Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma.
5 tips to score a job as a Life Science consultant
Job fair season is upon us! Whether you’re looking for your first job or a new work adventure, we can all agree that applying for a job comes with a healthy dose of nerves. To make sure you are the best version of yourself, preparation is key! Want to succeed in your next interview and land your QbDream job in consulting? Put your foot in the door and kick it wide open with these 5 tips!
Medical Device development: the importance of Design Transfer and Process Validation
Bringing a Medical Device to market involves many hurdles, including design and development. In this blog post, you will learn more about the importance of Design Transfer and Process Validation in medical device development.
QbD Group awarded Baanbrekende Werkgever ’23 certificate for the second year in a row
Today, on Nov. 14, 2022, we proudly received the Baanbrekende Werkgever ’23 certificate for the second year in a row, representing our commitment to put our employees at the center of our policies around hybrid work and mobility.
What is digital health? Exploring the landscape and future opportunities.
Digital health is on the rise, but what is digital health exactly? In this blog post, we’ll explore the landscape, key technology pillars and future opportunities.
21 CFR Part 11 compliance checklist: does your system comply?
21 CFR Part 11 regulates the use of electronic records and signatures in pharma and medical devices. Want to comply? Read more below and download our 21 CFR Part 11 compliance checklist.
Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy
Discover 5 reasons to engage with an experienced Contract Research Organization (CRO) specialized in medical device studies to support you in your clinical research.
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.
GAMP 5 Guide 2nd Edition: what’s new?
In 2022, ISPE released a new, second edition of the GAMP 5 guide. Read more about this new edition here and/or watch our webinar on demand.
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.
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 of the clinical evaluation strategyÂ
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 futureÂ
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 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 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 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!
QbD and TRIUM awarded with Baanbrekende Werkgever ‘22 certificate
On November 15, 2021, QbD and TRIUM received the Baanbrekende Werkgever ‘22 certificate for pioneering Belgian employers striving to put people at the center of their policies on hybrid work and mobility.
Dendritic cells: effective sentinels for immunotherapies
Dendritic cells play an important role in recently developed DC-based immunotherapies for the treatment of cancer, autoimmune diseases and the prevention of graft rejection. Read all about DC cells and their potential in this article.
Why NK cells are a major breakthrough in the field of ATMPs
NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.
Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.
From IVDD to IVDR: avoid these pitfalls to get your CE marking in time
In the EU, the IVDR will replace the IVDD. The compliance deadline is approaching, so act now to obtain CE marking of your IVD medical device in time.
Medical device combination products: what regulations should you apply before marketing them in the EU?
Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Guidance.
IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers
Learn more about the new risk-based approach to in-vitro diagnostic device classification under IVDR 2017/746, replacing outdated directives.
MDR impact on MDSW: what has changed from MDD?
The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more below.
Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more
Curious about the latest medical device industry trends? Learn more on wearables, AI, POC testing, IoT, and more in this blog post!
QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences
The QbD Academy is a young graduates program that combines working, learning and intensive training. Last month, we welcomed 15 young graduates during our QbD Academy Week. Read all about it here!
Unraveling Artificial Intelligence in Medical Devices: what do we know so far?
Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.
SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?
The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.
5 consequences of Brexit when selling medical devices in the UK
Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.
ATMPs: translating the expertise into a GMP process
ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.
QbD & TRIUM’s 10Y International Sports Challenge: a mix of fun, exercise, and team spirit!
Sports have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge! Read all about it here.
What is a medical device: key definitions and regulations around the worldÂ
Whether your product is a medical device depends on the markets you want to enter and their regulations. Here’s an overview to guide you.
Why Medical Device Risk Management is as complex as it is crucial
Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).
How QbD is investing in the new hybrid way of working
At QbD, we’re going the extra mile to put hybrid working to everyone’s advantage after COVID-19. Need some inspiration? Follow our lead!