Building a Quality Performance Evaluation Report (PER) as per Regulation (EU) IVDR 2017/746

Building a Quality Performance Evaluation Report (PER) as per Regulation (EU) IVDR 2017/746
The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements.