8. EU Expert Panels (MDR) • Understanding their influence on high-risk (Class III) device approvals and clinical evaluation reports (CERs). Discuss how to better prepare for EU expert panel review, especially for novel robotic systems? • Questions offered by Clinician / Industry Panel
9. Presubmission Pathways (US FDA Q-Sub) • Maximizing value from pre-sub interactions for RASD and AI-driven systems. Discuss common pitfalls seen in Q-Submissions for robotic systems, and how to optimize early engagement. • Questions offered by Clinician / Industry Panel
10. IMDRF & Regulatory Harmonization • Alignment across FDA, EU MDR, PMDA (Japan), NMPA (China) for AI/ML and robotic surgery. Discuss collaborative opportunities exist through IMDRF for harmonizing evidence requirements for robotic systems globally. • Questions offered by Clinician / Industry Panel
