How to write your Performance Evaluation? [IVDR 2017/746]

Medical Device made Easy Podcast · Apr 13, 2021

Subscribe

In this episode I have invited Hakan Inan from Requalite to help us understand the situation for In-Vitro Diagnostic device manufacturers and also on how to create a Performance Evaluation Report.

In this episode Hakan will provide you all the elements so that you have a good understanding of the Performance Evaluation process. This will include also so comparison to the EU MDR legislation and define if there are some commonality.

The IVDR industry should start urgently its transition to the EU IVDR 2017/746 and most importantly we will need more Notified Bodies to help these…