PEP and PER

On-Demand Webinar

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).

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. In this webinar, let you guide by our expert Julianne Bobela 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

Interested in learning how Medidee can help you throughout your Performance Evaluation Plan?

Get a free Performance Evaluation Plan Consultation now! Our experts will be back to you to find a time that works best for you!

CONTACT US NOW