QbD Group

Are you prepared to tackle the challenges of clinical performance studies under the IVDR? 💪 Join us on December 5 for a webinar where our IVD experts will guide you through the strategic, regulatory, and operational aspects of clinical performance studies under the IVDR. Can’t wait that long? We have good news! We’re releasing a series of 6 explainer videos to already provide you with critical insights into clinical performance requirements. Today’s video, featuring Kirsten Van Garsse and Maurizio Suppo, covers why clinical performance is key to a successful IVDR submission. Watch it now! 🔗 Register here for the webinar:👇 https://hubs.li/Q02WgC5X0 💡Stay tuned for weekly insights! #IVDR #ClinicalPerformanceStudies #IVD #InVitroDiagnostics

Advanced Therapy Medicinal Products (ATMPs) have revolutionized medicine, offering new treatments for once untreatable conditions. 🧬 The recent CAT Scientific Symposium celebrated 27 approved ATMPs, addressing everything from rare genetic disorders to advanced cancers. Read the full article to discover how CAT’s efforts have shaped the evolution of ATMPs. 👉 https://hubs.li/Q02VDqvS0 #ATMP #CAT

On November 11-14, you can find us at MEDICA - Leading International Trade Fair, the world’s leading trade fair for medical technology, diagnostics, health IT, and everything related to medical advancements. We’ll have two booths showcasing our expertise and services, each tailored to provide you with personalized advice and solutions for your needs. ✔️ Whether you’re looking to navigate complex European regulations for IVDs or learn more about how QbD Group can assist with your medical device, our team is here to help. See you there! 👋 https://hubs.li/Q02VYH8_0 #MEDICA2024 #MedicalDevices #InVitroDiagnostics

Last week, the members of our QbD Group Foundation combined fitness with environmental impact by going plogging—picking up litter while jogging/walking! 🏃♀️🗑️ Not only did they get some exercise, but they also helped to keep the neighborhood around our HQ clean. 💚💪 Want to learn more about the initiatives we're passionate about? Discover the QbD Group Foundation’s efforts here: https://hubs.li/Q02VPtT_0 #QbDGroupFoundation #Plogging #Sustainability #MakingADifference

As healthcare and patient safety take center stage, pharmaceutical companies are rethinking how they manage data and monitor the effects of their medications. 💊 At the heart of this shift is the growing role of Knowledge Process Outsourcing (KPO). Explore how strategic KPO is revolutionizing drug safety departments in the pharmaceutical industry, boosting efficiency, innovation, and ultimately, safer healthcare. 👇 https://hubs.li/Q02VCKTp0 #Pharma #KnowledgeProcessOutsourcing #KPO #Healthcare

What an achievement! 27 QbD'ers laced up their running shoes and conquered the Antwerp Marathon this weekend! Whether they took on the 10 km, half marathon, or the marathon, they gave it their all and crossed the finish line with pride.🏃♂️🥇 Way to go, team! You truly embody our QbD spirit of going the extra mile (literally and figuratively)! 💪 #ExtraMile #Marathon #Joy #TeamQbD

Did you know it's been more than 3 years since the European Medica Device Regulation (MDR) came into effect? 💡 One of the goals of the MDR was to enhance the quality and reliability of clinical data, which significantly impacted clinical investigations with medical devices. That’s why our Clinical Regulatory Experts have developed this whitepaper, packed with insights and practical experiences to help you stay ahead of the evolving regulatory landscape. 🔑 What's inside: - The ongoing harmonization in the authorization process by regulatory authorities and ethics committees, - The evolving role of the EU Legal Representative for sponsors outside Europe, - The impact of the MDR on study conduct, with stricter requirements for safety reporting and post-market surveillance and future developments. 🔗 Download here: https://hubs.li/Q02Vg_HF0 #MDR #ClinicalInvestigations

Struggling to create MDR-compliant technical documentation for your Medical Device Software? We’ve reached the final session of our 5-part webinar series, and you won’t want to miss it! This Thursday, Caroline will guide you through interpreting MDR requirements, choosing the right accredited Notified Body, and understanding the qualification and classification process—all with your software’s Intended Purpose in mind. 🔍 Get the practical insights you need to craft essential technical documentation with confidence. 👉 Register today: https://hubs.li/Q02V3NRT0 #MDSW #MDR #MedicalDeviceSoftware #TechnicalDocumentation

Feeling overwhelmed by lab compliance? You're not alone! 🔬 This whitepaper is your guide to learn essential strategies for: - Maintaining data integrity - Ensuring quality management - Meeting rigorous regulatory standards It's a must-read for laboratory professionals seeking to optimize operations and maintain high compliance standards. 🔎✔️ https://hubs.li/Q02TnTv-0 #LaboratoryCompliance #QualityManagement #DataIntegrity #Regulatory

This month, our yearly QbD Quiz took place, and wow, what an evening it was! After a delicious pasta feast, it was time to put our brains to the test. 🍝🧠 23 teams gave it their all, but it was 'The Babboons' who took home the trophy. Congratulations Laura, Jasper, Filip, Eline, Bernd, and Charlotte! 🏆 And of course, a round of applause for Henrik, who debuted as our "quizmaster extraordinaire", and for our dedicated team who diligently corrected all the answers. 👏 #QbDQuiz #Joy #Teamwork