Webinar: Personalised Medical Devices – what you need to know

What’s this webinar about?

The Medical Device Regulation (MDR) is fully applicable in the EU since 26 May 2021. The timelines for ensuring your product achieves or maintains EU market access under the new, more stringent MDR are challenging. Our webinar will provide you with useful information around the routes to conformity for personalised medical devices under the MDR. 

Who should attend the webinar?

This webinar will be useful to manufacturers of personalised medical devices and anyone with an interest in the regulatory paths for personalised medical devices. Also, anyone who is involved with classification of personalised medical devices, will also find this webinar insightful.

What will participants gain?

Join Dr Tim Marriott, Senior Technical Specialist and Scheme Manager, BSI, to hear about important insights into routes to conformity for personalised medical devices. Tim will also be joined by Judith Prevoo, Regulatory Lead, BSI. Participants will gain an understanding of the regulatory requirements for personalised medical devices as well as an explanation of common pitfalls of classifying personalised devices.

Dr Tim Marriott has 15 years of orthopaedic medical device experience, ranging from fundamental research in biomaterials and biomechanics, product verification and validation studies, risk management, manufacturing fault finding and validation, regulatory documentation, failure analysis and interpretation of clinical data.

Tim joined BSI in 2017 and prior to this worked in the Research team at Zimmer Biomet where he worked throughout the organisation to bring products to the market from conception. Tim graduated from a biomedical materials science degree and has a PhD in Biomaterials from Nottingham University.

Judith Prevoo is a Regulatory Lead for BSI The Netherlands Notified Body and she is responsible for the regulatory oversight of medical devices Notified Body strategy, policy, procedures and documentation to meet the various legislative and designation requirements.

Before joining BSI in 2018, she gained over 13 years’ experience in the In Vitro Diagnostic medical device and pharmaceuticals industries in both scientific and Quality Assurance roles.