QbD Group

The FDA is changing the rules, and startups can’t afford to wait. From February 2, 2026, the new Quality Management System Regulation (QMSR) replaces the old QSR. It’s not just a regulatory update; it’s a shift toward global alignment with ISO 13485:2016. 👉 In this carousel, we break down: ↳ What’s actually changing ↳ Why it matters for MedTech startups ↳ The 7 actions you should take now to stay inspection-ready 🔗 Read the full article on our Knowledge Center: https://lnkd.in/de59nyT9 #QMSR #FDA #ISO13485 #MedTech #QualityManagement #Startups

Last week our team had a lovely time at CPHI Frankfurt. Over three days, we welcomed many visitors to our booth, exchanged insights, and discussed the challenges and opportunities shaping the industry. From regulatory questions to expanding into the European market, it was inspiring to connect with so many people. 🤝 We also had the pleasure of hosting a networking dinner for a select group of customers and industry peers. The private, relaxed setting away from the busy exhibition halls offered the perfect moment to strengthen relationships, share perspectives, and explore what it truly takes to enter and grow in the European life sciences landscape. A big thank you to everyone who stopped by, shared their experiences, and joined us at the dinner. We look forward to continuing the conversation and supporting your journey in Europe and beyond. 🌍 #CPHIFrankfurt #MarketAccessEurope #Pharma

Under the MDR, usability testing is no longer a “nice-to-have.” It is a core component of risk management, ensuring devices are not only technically safe, but also intuitive and effective in the hands of real users.   In our latest blog, we unpack how early, structured usability testing helps reduce risk, improve device safety, and support regulatory approval. 👇 🔗 https://lnkd.in/gGNQg6NV 💡 Want to quickly identify hidden gaps in your MDR file? Take our MDR Blind Spot Check and see what could jeopardize your CE approval or trigger costly non-conformities. 🔗 https://lnkd.in/eA8hFS8D #MDR #MedicalDevices #UsabilityTesting

Last week, together with KU Leuven, we hosted our annual #Glioblastoma Research Chair update event. This initiative remains close to us as a company. Since Pieter Van Vlierberghe, a dear friend of Frederik De Smet and our CEO Bart Van Acker, was diagnosed in 2020, the QbD Group Foundation has been supporting the glioblastoma research chair led by Frederik. Pieter sadly passed away at the end of 2022, and we continue to honor his memory by contributing to this important research. 🤍 The evening began with an exclusive look inside the research lab, followed by a walking dinner and presentations from Laurence Carlier, Prof. Johan Van Lint, Prof. Frederik De Smet, and Dr. Carmen Bravo. Thank you to KU Leuven and to all speakers for the collaboration and commitment to advancing glioblastoma research. 🙏

Scaling your pharmacovigilance (PV) operations across Europe requires more than regulatory knowledge. It demands seamless alignment between data, systems, and people, all operating under Good Pharmacovigilance Practices (GVP) without adding unnecessary operational complexity. So how do you build PV capabilities that scale efficiently and compliantly? We break it down in our latest blog: 🔗 https://lnkd.in/gyvubvR4 And if you would like to explore the topic even further: 📅 Join our webinar on November 13 at 16:00 CET Whether you are building your first global pharmacovigilance framework or optimizing an existing one, you will gain clear and practical strategies to scale across Europe. Save your seat! 👇 https://lnkd.in/gNAxTMSn #GVP #Pharmacovigilance #Europe

We’re asked about Computer Software Validation (CSV) every day by clients, partners, and industry stakeholders. From regulatory frameworks like GAMP 5 and 21 CFR Part 11 to the role of AI in validation, the landscape is complex, and the questions keep coming. That's why we’ve put together a practical FAQ guide with 45+ questions from the field such as: 💬 How can we determine if our software complies with 21 CFR Part 11? 💬 When should we start considering CSV? 💬 What are the key benefits of adopting paperless validation? 💬 Can we integrate AI and still stay compliant? ... 🔗Download the full FAQ: https://hubs.li/Q03QwJvz0 #Digitalization #CSV #FAQ

We’re happy to share a new edition of our #Pharma newsletter! This issue shines a spotlight on two key themes shaping the industry today: #Digitalization in the pharmaceutical industry and scaling #Pharmacovigilance in Europe. Beyond these highlights, you’ll also find expert insights on outsourcing stability studies, lessons learned in nitrosamine control, and much more. Ready to dive in? Happy reading! 📰☕

This week, we took a moment to celebrate a truly incredible milestone: Hannah Dreesen's 10-year work anniversary with us! 🎉 What's really special is that Hannah was actually the second-ever HR colleague at QbD Group. That means she's been a foundational part of the QbD story, seeing us through thick and thin, and helping to build the amazing team we have today. There were heartfelt speeches and a few happy tears as we looked back on her journey. Here’s to you, Hannah, and to many more amazing years! ✨ #WorkAnniversary #QbDGroup

Scaling pharmacovigilance (PV) across Europe is as much an organizational challenge as it is a regulatory one. The operating model you choose - centralized, hybrid, or decentralized - determines how well you: ✅ balance global consistency with country-specific requirements, ✅ maintain a robust PV quality system, ✅ stay compliant with Europe’s stringent case management and signal obligations. Getting this balance right is key to sustainable EU growth. Read the full blog and join our upcoming webinar to dive deeper. 🔗 Blog: https://lnkd.in/eZxwHRkX 🎙️ Webinar: https://lnkd.in/gNAxTMSn #Pharmacovigilance #EU #Pharma

Have you ever considered using in-silico testing to support your MDR compliance? 🤔 In-silico testing, which uses computational modeling and simulation techniques, is a powerful method to strengthen your technical file. 💻 It’s particularly valuable in the early design stages, where it can (re)direct device development before physical testing begins. Regulatory bodies increasingly recognize in-silico testing as valid supporting evidence, alongside traditional pre-clinical and clinical studies. In this blog post, we explain what in-silico testing is, how it supports MDR documentation, and how to integrate it into your technical file. 👇 https://lnkd.in/eZtxysfz Your next step? Take our quick MDR blind spot check to uncover the in-silico testing gaps that could block your CE approval. 🔗 https://lnkd.in/eA8hFS8D #MDR #InSilicoTesting