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Program

April 25th, 2025
  • 9:00 - 9:10 Bijan - Welcome, Opening remarks
    Plenary
  • 9:10 - 9:55 Keynote - Rick Wedge |Susan Neadle
    Plenary
  • 9:55 - 10:30 Break
  • 10:30 - 11:15 Zhao - Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: A Regulatory and Lifecycle Approach to Safety and Effectiveness
  • 11:15 - 12:00 Badwal - Risk Management Challenges for AI/ML-Enabled Medical Devices: Integrating SaMD and Hybrid Systems
  • 12:00 - 13:00 Lunch break
  • 13:00 - 13:30 Morel - Review of quantitative methods for overall benefit-risk determination
  • 13:30 - 14:00 Blom - Justification for a method setting severity levels to increase vigilance efficiency and avoid non-conformities / inspection observations
  • 14:00 - 14:30 Break
  • 14:30 - 15:15 Vroonhoven - Future of ISO 14971 and other standards
  • 9:00 - 9:10 Bijan - Welcome, Opening remarks
    Plenary
  • 9:10 - 9:55 Keynote - Rick Wedge |Susan Neadle
    Plenary
  • 9:55 - 10:30 Break
  • 10:30 - 11:15 Dieringer - Unlocking Post-Market Data with Thresholds: The Key to Effective Risk Management and Compliance
  • 11:15 - 12:00 Bano - Navigating the Risk Landscape of Combination Products: Strategies for Safety and Lifecycle Management
  • 12:00 - 13:00 Lunch break
  • 13:00 - 13:30 Krenc - Finding Normal Condition Risk - It isn't in your FMEA!
  • 13:30 - 14:00 Hodes - Patient Safety Clinicians' Roles in Industry Risk Management
  • 14:00 - 14:30 Break
  • 14:30 - 15:15 Vernacchia - Using System Theoretic Process Analysis (STPA) in Medical Systems Risk Management