Do you know? A non-compliant IVDR performance evaluation report poses risks during the authorization process and risks patient safety. This paved the path for strict and robust IVDR requirements on the performance evaluation of IVDs. How to gather clinical data for IVD, and are there any best practices to be followed to write a compliant PER? Gain insights with Freyr’s thought leadership published in Med Device Online, authored by Priya Ray Chaudhuri, Medical Writing Lead, Medical Devices Centre of Excellence (COE) at Freyr Solutions. 

Global HA Mandates