Structuring PERs under IVDR

Whether you are interested in improved strategies for completing PERs or effectively completing your first PER, our April 2020 webinar can act as a critical guide.

You are probably familiar with the increased requirements for clinical performance under the new IVDR. Whether you are interested in improved strategies for completing Performance Evaluation Reports (PERs) or learning the ropes so you can efficiently and effectively complete your first PER, this webinar can act as a critical guide. The focus points of this webinar will be:

─  How to structure your PERs under IVDR and what elements to consider for PER templates
─  Making sense of and leveraging MEDDEV 2.7/1 Rev. 4 and GHTF guidance documents
─  How to conduct literature searches for PERs
─  A summary of things to consider to enable your organization to comply by the 2022 IVDR date of application

The webinar will also cover issues such as State of the Art, scientific validity reports, and analytical performance reports will be addressed, as well as the role of Post-Market Clinical Follow Up (PMPF).

In the end, attendees of this webinar will leave with the ability to impact their organizations with a clear understanding of the regulations and actionable takeaways to help their organization move towards IVDR compliance.