Overview of Medical Devices Regulation and the Challenges Ahead
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The aim of the event is designed to provide SMEs with an understanding of the Medical Device Regulation/In Vitro Diagnostic Device Regulations (IVDR).

Speakers:

Alison Bray, Lead Clinical Scientist, Medical Device Development Service, Northern Medical Physics and Clinical Engineering from Newcastle upon Tyne Hospitals NHS Foundation Trust, will provide an understanding of the Medical Device Regulation/In Vitro Diagnostic Device Regulations (IVDR)

Alison has worked within Medical Physics at Newcastle Hospitals for the last 10 years on various research and development projects in the field of novel medical devices. Since November 2019 she has led the Medical Device Development Service with a view to implementing a quality system according to ISO 13485.

Dr. Tom Beale CPhys, Commercial Development Manager – Medtech from CPI will share insights on developing medical devices for manufacture and commercialisation within a regulated environment.

Tom leads the Medtech offering at CPI. He has extensive experience in assisting companies in developing medical devices for clinical use, from regulatory compliance to product development and device adoption. Tom joined the NHS within clinical engineering - designing and developing diagnostic and therapeutic medical devices for commercial exploitation, and providing guidance for regulatory compliance.

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