[WEBINAR] Performance Evaluation Plan & Report

With the implementation of the IVDR, for In Vitro Medical devices (IVD), a performance evaluation needs to be conducted to demonstrate a device’s performance and safety evidence. This performance evaluation follows a defined Performance Evaluation Plan (PEP) and is documented within a Performance Evaluation Report (PER).


But what exactly is a performance evaluation and what does it consist of?
What are the IVD devices which need a performance evaluation?
How do I establish the strategy for performance and safety substantiation?
When is the right moment to start with a device’s performance evaluation?
What about legacy devices?
Is there any guidance or a standard that I can use?


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


· The documentation which constitutes a performance evaluation
· The type of data needed to support a device’s performance and safety
· The device-specific needs for performance evaluation, based on its group, risk class, and intended purpose
· The lifecycle of a performance evaluation and its interconnection with other documents of the technical documentation


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