May 30, 2025
Carmen Bellebna, our Head of Regulatory Affairs at deepeye Medical, was invited by Monir El Azzouzi to join the latest episode of the Easy Medical Device podcast!
🎧 Episode #337: “Navigating the EU AI Act & MDR Certification: deepeye Medical’s Success Story”
🕒 Duration: 43 minutes
📺 Watch here:
Carmen walks through our journey of aligning deepeye® TPS, an AI-based decision support software for nAMD therapy with both the EU AI Act (Regulation (EU) 2024/1689) and EU MDR (Regulation (EU) 2017/745) requirements.
She shares first-hand insights into:
✅ What the EU AI Act means for AI-driven medical devices
✅ How we harmonized AI system design with MDR clinical benefit and safety criteria
✅ Challenges in technical documentation, conformity assessment, and notified body interactions
✅ Practical advice for building a compliant QMS tailored for AI-powered softwareThis episode is a must-listen for anyone working at the intersection of AI, MedTech, and EU regulatory frameworks.
You’ll learn:
00:00 – 05:10 Introduction to deepeye Medical & guest Carmen Bellebna
05:10 – 15:25 What the EU AI Act (Regulation (EU) 2024/1689) entails and its key risk-based obligations
15:25 – 24:45 Aligning AI systems with EU MDR requirements for SaMD and clinical benefit
24:45 – 33:30 Challenges faced by deepeye: technical documentation, conformity assessment, and notified-body interactions
33:30 – 42:50 Practical takeaways: building a compliant AI-driven medical device QMS
