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Usability Testing and MDR: Managing Risk with the Human Factor
Under the EU Medical Device Regulation (MDR), usability is no longer a...
Anne-Sophie Grell
Manager Regulatory Affairs – Medical Devices | PhD in Physics | MSc in Medical Physics
Anne-Sophie Grell is a highly respected Regulatory Affairs leader with over two decades of multidisciplinary experience in medical physics, diagnostic imaging, and medical device regulation. At QbD Group, she supports clients navigating EU MDR, FDA, and international regulatory frameworks, especially for high-tech devices in radiology, radiotherapy, and proton therapy.
Biography
Anne-Sophie Grell holds a PhD in Physics (2001) and a Master’s in Medical Physics (2006). She began her career as a researcher and physics control lead in medical imaging at the Institut Jules Bordet, and quickly established herself as a trusted authority in radiology quality control and medical device compliance.
Her deep expertise earned her appointments as board member of the Belgian Association for Medical Physicists and effective member of the Belgian Federal Health Agency’s medical device evaluation commission. In 2010, she transitioned to the industry side, joining IBA as QA/RA Manager, and later RA Director, overseeing both medical and non-medical device portfolios.
At IBA, Anne-Sophie led global registration strategies and was instrumental in proton therapy upgrade projects. She later joined Philips IGTD as Senior RA Expert and APAC Regional Lead, managing submissions and market access across Russia, China, India, New Zealand, and more.
Since 2021, she has been Manager RA PD at QbD, where she leads regulatory strategies for X-ray, MRI, radiotherapy, and AI-powered imaging devices, with a strong focus on EU MDR, ISO 13485, ISO 14971, and global market registration.
Awards, Recognitions & Affiliations
- Board Member, BHPA (2007–2010)
- Expert in Medical Physics – FANC, 2007
- Recognized expert in mammography screening – Belgian Ministry, 2010
- RAPS Member (2010–2019, 2021–present)
- ISO 13485 Internal Auditor – Certified by BSI
- Member of Team PRRC (2022–present)
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