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    • Webinar
      Medical Devices

    ISO 20916 IVD — Clinical performance studies

    ISO 20916 is a new standard addressing requirements for clinical performance studies on IVD medical devices.

    Watch the Webinar View the Presentation

    This Webinar:

    • Clinical performance studies using specimens from human subjects — Good study practice.

    • Planning, design, conduct, recording and reporting of clinical performance studies.

    • Assessing the clinical performance and safety of IVD medical devices for regulatory purposes.

    • Standard ISO 20916 In vitro diagnostic medical devices.

    Contributors

    ISO 20916 IVD — Clinical performance studies

    Information presented within this webinar is based on our current understanding of the IVDR standards.

    Contributor

    Dr Marco Rost

    IVD Training Lead, BSI.

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