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How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body

Authors: Carmen Giefing-Kröll, Geneviève Laumen

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting essential requirements with harmonised standards, post market surveillance, and vigilance. She has a Bachelor’s and Master’s in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford). Prior to working for BSI, she has designed orthopaedic implants and conducted post market clinical investigations on these products.  The EU Medical Device Regulation (MDR) has drastically changed the regulatory environment for medical devices and reinforced the requirements on clinical evidence and the post-market surveillance. We are glad to have interviewed Suzanne Halliday for this issue of MEW with special focus on medical devices.

Medical Writing. 2022;31(2):62–64

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