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Location/Live Stream
IRCAD
IRCAD
Le Palais de Congres
Le Palais de Congres
Live Streaming
Live Streaming

Plenary 2: Medical Device Regulation

Plenary 2: Medical Device Regulation

Session 5: Training and Security

Wednesday, July 16, 2025
5:00 PM - 5:30 PM CEST
Location: Palais de Congres- Schweitzer Auditorium
Le Palais de Congres Live Streaming
11. Cybersecurity and Data Privacy in Robotic Platforms
• Safeguarding sensitive patient and procedural data in connected surgical environments. How regulators assess cybersecurity preparedness, and what emerging standards should manufacturers align with (e.g., ISO 27001, NIST)?
• Questions offered by Clinician / Industry Panel

12. Regulatory Sandbox Initiatives
• Participation in sandbox pilots (e.g., FDA’s Digital Health Center of Excellence, MHRA’s AI Airlock). How manufacturers may participate in regulatory sandbox initiatives for emerging technologies like AI and telesurgery.
• Questions offered by Clinician / Industry Panel

13. Training & Credentialing Requirements
• Regulatory expectations for training validation, proctoring, and competency tracking. How regulators view the role of simulation and AI-driven training in ensuring consistent operator performance.
• Questions offered by Clinician / Industry Panel