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 device manufacturers
- International regulatory harmonization efforts - Key Dos and Don’ts when interacting with regulators
Digital Health Section Podcast- Royal Society of Medicine