Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA
Digital Health Podcast- Royal Society of Medicine
- Published
- July 14, 2024
- Duration
- 40:58
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses ai-regulation.
Summary
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 -…
Show notes
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
Themes
- ai-regulation