Thursday, 15 October 2026 | 13:20 - 14:35
B1: Bridging regulation and reality: AI in medical devices under MDR and additional regulations
Location:Room 1: Maria Theresia
- 13:20: Daniela Seneca: Gaps & Practical Challenges on Medical Device Artificial Intelligence conformity assessment: Perspectives from a Notified Body
- 13:45: Dilnaz Sugralina: FDA Clearance and Maintenance of AI Medical Device Software: An EU Manufacturer’s Perspective
- 14:10: Aravinda Kumaran: Bringing AI-Powered Medical Devices to Market: Lessons from EU Technical Documentation and the Road to FDA Submission
3 speakers
Quality & Regulatory Affairs Manager
SCARLETRED Holding GmbH
Regulatory Lead AI
BSI Group
Scientific & Regulatory Affairs Manager
piur imaging GmbH