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Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA
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
View all episodes
By RSM Digital Health CouncilThis 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
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