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    • Webinar
      Medical Devices

    Pathways to IVDR Compliance

    This webinar presents an overview of the key aspects of IVDR compliance, focusing on technical documentation and Performance Evaluation.

    Watch the Webinar View the Presentation

    This Webinar:

    • History Lesson: Key IVDR changes… why and when?

    • Telling a Story: Creating effective technical documentation.

    • Clinical Evidence: Understanding the requirements.

    • High Risk update: Current status of CDx & Class D devices.

    Contributors

    Pathways to IVDR compliance

    Overview of IVDR compliance, focusing on pitfalls related to technical documentation and Performance Evaluation requirements under IVDR Regulation.

    Contributor

    Elizabeth Harrison

    Global Head - IVD, BSI.
    Contributor

    Alex Laan

    Head of IVD Notified Body, BSI.
    Contributor

    Todd Moorman VP

    IVD Sales Solution, Americas, BSI.
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