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.

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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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