AI/ML Medical Devices: US & EU Regulatory Pathways

This program provides participants with a comprehensive understanding of the evolving regulatory landscape for AI/ML-based medical devices in the US and EU. Delivered by an industry veteran with over 25 years of expertise, the course explores the FDA’s AI/ML Action Plan, EU MDR/IVDR requirements, and the practical challenges of securing approvals for adaptive algorithms. Through real-world case studies, interactive classification exercises, and simulations, participants will learn how to address issues like algorithm transparency, bias, cybersecurity, and lifecycle compliance. The program equips teams with actionable strategies to design regulatory submissions that accelerate approvals while reducing compliance risks.