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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 2: Clinical Data, Testing, and Indications for use in RASD

Wednesday, July 16, 2025
2:45 PM - 3:15 PM CEST
Location: Palais de Congres- Schweitzer Auditorium
Le Palais de Congres Live Streaming
1. Clinical Data Requirements
• What evidence thresholds are evolving for complex devices like robotic systems? How do regulators view RWE in complementing traditional clinical data?
• Questions offered by Clinician / Industry Panel

2. Usability Testing
• Emphasis on human factors engineering and surgeon training validation.
• Questions offered by Clinician / Industry Panel

3. Post-Market Surveillance (PMS)
• PMS integration with AI monitoring and digital feedback loops; proactive risk management (PRM).
• Questions offered by Clinician / Industry Panel

4. Indications for Use (IFU)
• Aligning IFU evolution with new procedural evidence and AI enhancements, discussion of umbrella procedures and similar procedures, use of RWE for indication expansion
• Questions offered by Clinician / Industry Panel