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Full Schedule

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Full Schedule

  • Thursday, October 26, 2023
  • 08:00 – 16:30 CET
    Registration
  • 09:00 – 10:00 CET
    Clinical Evaluation of Medical Devices With AI: What we Know Now.
  • 09:00 – 10:00 CET
    Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Compliant CER
  • 10:00 – 10:30 CET
    Coffee Break
  • 10:30 – 11:30 CET
    Clinical Evidence Under IVDR - How Much is Sufficient?
  • 10:30 – 11:30 CET
    Understanding the Role of ISO 14155 Under MDR
  • 11:45 – 12:45 CET
    Considerations of EU Expert Panel Opinions - What Have we Learned?
  • 11:45 – 12:45 CET
    Post-Market Surveillance Under IVDR
  • 12:45 – 13:45 CET
    Lunch
  • 13:45 – 14:45 CET
    Clinical Decision Support Software - Considerations and Challenges for Classification and Clinical Evidence
  • 13:45 – 14:45 CET
    Clinical Evaluation Reports: Misconceptions and How to Strategize Towards Perfection
  • 14:45 – 15:15 CET
    Coffee Break
  • 15:15 – 16:15 CET
    Closing Plenary: Qualitative vs Quantitative: How do I Determine the Benefit-Risk for my Device?