[WEBINAR] Clinical Investigation & In Vitro Diagnostic Devices

With the implementation of the IVDR, clinical performance studies on In Vitro Diagnostic Medical devices are becoming a central pillar of the device’s clinical evidence.

But what exactly is a clinical performance study?
Which IVD devices require collection of clinical evidence through a clinical performance study?
When is the right moment in a device’s lifecycle for conducting a clinical performance study?
How do I handle clinical data gathered through previous clinical performance study?
Is it mandatory to use the ISO 20916 standard?


In order to avoid delays in the marketing approval process, it is important to understand the full clinical workflow for each type of IVD device. Join us for this on-demand webinar during which our expert Julianne Bobela will guide you through an IVD’s Clinical workflow, including:

· The type of clinical data needed
· The device-specific needs for clinical performance studies
· The characteristics of interventional clinical performance studies
· The regulatory requirements for conducting clinical performance studies

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