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Full Schedule

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Full Schedule

  • Tuesday, October 24, 2023
  • 08:30 – 17:00 CET
    Registration
  • 09:00 – 16:15 CET
    Preconference Workshop: Clinical Evaluation Toolkit
  • Wednesday, October 25, 2023
  • 08:00 – 17:00 CET
    Registration
  • 09:00 – 10:00 CET
    Opening Remarks & Plenary Session: Navigating Evolving Regulatory Landscape in Europe
  • 10:00 – 10:30 CET
    Coffee Break
  • 10:30 – 11:30 CET
    Developing Your Clinical Strategy
  • 10:30 – 11:30 CET
    Risk Management Throughout the Product Lifestyle
  • 11:45 – 12:45 CET
    FMEA is Not the Only Way
  • 11:45 – 12:45 CET
    Sufficient Clinical Evidence for Medical Device Under MDR
  • 12:45 – 13:45 CET
    Lunch
  • 13:45 – 14:45 CET
    Medical Device and Pharmaceutical Risk Management Approaches - What can we Learn Together?
  • 13:45 – 14:45 CET
    The Value of Real World Evidence
  • 14:45 – 15:15 CET
    Coffee Break
  • 15:15 – 16:15 CET
    Usability in Risk Management (MD & IVD)
  • 15:15 – 16:15 CET
    WET: What we Know and What we Don't
  • 16:30 – 17:30 CET
    Clinical Evaluation in the MDR Era: Mastering the Equivalence Route
  • 16:30 – 17:30 CET
    Streamlining Clinical Evaluation, Risk Management and PMS- the Medical Device Knowledge Unit approach
  • 17:30 – 18:30 CET
    Networking Reception
  • 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?