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