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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