Digital Health Podcast- Royal Society of Medicine
Discover how digital technologies are transforming healthcare through interviews with leading digital health experts. Presented by Dr Annabelle Painter All views expressed in this podcast are of the speakers themselves and not of the RSM. Find out more about the RSM digital council: rsm.ac/dhsectionpodcast Hosted by Annabelle Painter: www.linkedin.com/in/dr-annabelle-painter/
Filtered episodes(2)
- StandardSummaries onlyThe future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet
Published Dec 3, 2024
In this episode focusses on the future of regulatory approvals for AI software medical devices in the UK (and EU). Featuring guest James Dewar- Co-founder of Scarlet a EU Notified body and UK approved body that specialises in certifying software medical devices. Key discussion topics: The current regulatory position of the UK post-Brexit and the opportunities that this could present The practical impact of the EU AI act for medical device manufacturers within the EU. What makes regulatory submis
- StandardSummaries onlyRegulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA
Published Jul 14, 2024
This episode explores software as a medical device regulation on both sides of the Atlantic. It features two incredible guests, Johan (ex-MHRA) and Brendan (ex-FDA) who share their unique perspectives from their respective experience at regulatory agencies. Discussion points include: The key differences between the EU, UK and US approaches to regulation - How these differences impact market entry strategy - Approaches to regulating AI including the EU AI Act and what it means for AI medical devi