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
