EPISODE · Oct 13, 2025 · 37 MIN
Fundamentals of Medical Device Regulations for AI
from LEAPcast · host LEAP Digital Health Hub
Dr Paul Jewell (Assuric) provides practical advice for developers looking to balance patient safety with cutting edge innovation.Join us as we delve into the evolving UK landscape of regulation for AI and LLMs, and what innovators should be doing to prepare. Links to guidance and regulation mentioned in the show:Medical Device Definition from the MHRA How to tell if your product is a medical device (MHRA) MHRA guidance on digital mental health technologies MDR 2002 EUMDR 2021 Sign up to the LEAP Digital Health Hub mailing list hereProduced by Karen Louise Dawe PhD and Emily Nielsen PhD
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Fundamentals of Medical Device Regulations for AI
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