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Full Schedule

Full Schedule

  • Tuesday, May 11, 2021
  • 10:00 – 10:30 CEST
    Risk Management: Compliance with Risk Management Requirements in ISO 14155:2020 During Different Clinical Development Stages of Clinical Investigations for Medical Devices, Including SaMD
  • 10:00 – 11:00 CEST
    MDR Technical Overview: How to Navigate in the Waters of MDR implementation and Which icebergs to Avoid
  • 10:00 – 11:00 CEST
    Pandemic Readiness - Business Contingency
  • 10:00 – 11:00 CEST
    Pressure cooker: Fast Track to IVD-R Compliance
  • 10:00 – 17:00 CEST
    Poster Gallery Viewing
  • 10:00 – 19:00 CEST
    Sponsor Solutions - Visit Sponsor Booths
  • 10:30 – 11:00 CEST
    Making the Risk Management File work for to you to support safety and efficacy of devices.
  • 11:00 – 11:15 CEST
    Meet The Speaker - MDR Technical Overview
  • 11:00 – 11:15 CEST
    Meet The Speaker - Pandemic Readiness
  • 11:00 – 11:15 CEST
    Meet The Speaker - Pressure Cooker
  • 11:00 – 11:15 CEST
    Meet The Speaker - Risk Management
  • 11:15 – 12:00 CEST
    Visit Sponsors - Brain Break
  • 12:00 – 13:00 CEST
    Data Security and Digital Health
  • 12:00 – 13:00 CEST
    Innovative Regulatory Decision Making - Optimised Development Strategies
  • 12:00 – 13:00 CEST
    IVDR Implementation Best Practices and Challenges
  • 12:00 – 13:00 CEST
    MDR Technical Documentation – How to approach important requirements today and in future
  • 13:00 – 13:15 CEST
    Meet The Speaker - Data Security and Digital Health
  • 13:00 – 13:15 CEST
    Meet The Speaker - Implementation Best Practices & Challenges
  • 13:00 – 13:15 CEST
    Meet The Speaker - Innovative Regulatory Decision Making
  • 13:00 – 13:15 CEST
    Meet The Speaker - Technical Documentation
  • 13:15 – 14:00 CEST
    Lunch Break - Visit Sponsors - Brain Break
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Germany Chapter
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Netherlands Chapter
  • 13:15 – 14:00 CEST
    Meet and Greet: RAPS Switzerland Chapter
  • 13:30 – 14:00 CEST
    Meet the Authors - Software as a Medical Device
  • 14:00 – 14:45 CEST
    All Paths Begin with Clinical Evidence, But Where Can I Go?
  • 14:00 – 14:45 CEST
    Boosting IVDR Transition with Workforce of IVD-industry Experienced Partners
  • 14:00 – 14:45 CEST
    Transforming Regulatory Affairs
  • 15:00 – 16:00 CEST
    Digitalisation in Health Care / (Real World) Evidence & Innovative Technologies
  • 15:00 – 16:00 CEST
    Recognition of CE Marking Outside EU During Transition Period
  • 15:00 – 16:00 CEST
    Risk Management
  • 15:00 – 16:00 CEST
    Software as a Medical Device, Mobile apps, Wearables
  • 16:00 – 16:15 CEST
    Meet The Speaker - Digitalisation in Health Care
  • 16:00 – 16:15 CEST
    Meet The Speaker - Recognition of CE Marking Outside EU During Transition Period
  • 16:00 – 16:15 CEST
    Meet The Speaker - Risk Management
  • 16:00 – 16:15 CEST
    Meet The Speaker - Software as a Medical Device, Mobile Apps, Wearables
  • 16:15 – 16:30 CEST
    Brain Break - Visit Sponsor Booths
  • 16:30 – 17:30 CEST
    Patient Engagement Focused Drug Development
  • 16:30 – 17:30 CEST
    Postmarketing Clinical Follow-up (PMCF)
  • 16:30 – 17:30 CEST
    Reflection on Pandemic
  • 16:30 – 17:30 CEST
    Turbulent Times in Europe: Why the US is taking over the lead in Medical Technology Innovation
  • 17:30 – 17:45 CEST
    Meet The Speaker - Patient Engagement Focused Drug Development
  • 17:30 – 17:45 CEST
    Meet The Speaker - Postmarketing Clinical Follow-up (PMCF)
  • 17:30 – 17:45 CEST
    Meet The Speaker - Reflection on Pandemic
  • 17:30 – 17:45 CEST
    Meet The Speaker - Software-related Medical Technology
  • 18:00 – 19:00 CEST
    Poster Session: IVDR & Medical Devices
  • 18:00 – 19:00 CEST
    Poster Session: Pharmaceuticals