Entering the European MedTech Market: Why One Approval Doesn't Fit All

Anne-Sophie Grell

Business Unit Manager Regulatory Affairs - Medical Devices

Anne-Sophie Grell is Business Unit Manager Regulatory Affairs Medical Device at QbD Group, with over two decades of experience in medical physics, diagnostic imaging, and global medical device regulation. She holds a PhD in Physics and began her career as an MRI researcher in a cancer hospital before completing a Master's in Medical Physics, where she supported quality control activities across imaging and radiotherapy. In 2010, she transitioned to the private sector, taking on leadership roles in Quality and Regulatory Affairs within the medical device industry. Over the years, she has worked closely with Competent Authorities and Notified Bodies worldwide, shaping international registration strategies and regulatory pathways. At QbD, she supports manufacturers in defining and executing robust regulatory strategies to successfully bring their medical devices to the European, US, and Asian markets.

Petra De Geest

Clinical Evidence & Safety Lead

Petra is a Clinical Evidence and Safety Lead at QbD Group with over 12 years of experience across clinical practice, clinical research, and the medical device industry. She holds a Master's degree in Sports Physiotherapy and spent 10 years in clinical practice supporting both professional and non-professional athletes before transitioning into Clinical Research, where she took on roles in Clinical Operations and Safety Management. She later served as Clinical Evaluation Lead for a medical imaging device manufacturer. At QbD, Petra combines her expertise in clinical safety and evidence generation with strategic support for manufacturers in building robust clinical documentation and navigating EU MDR requirements to successfully bring their products to the European market.