Tag Archives: periodic safety update report medical device

Articles 86 of European MDR 2017/745 units out necessities for Periodic Safety Update Report (PSUR) and standard contents of PSUR are as follows:  the belief of advantage-threat determination:  advantage-threat analysis is a non-stop manner, that’s a part of danger management procedure and it needs to be done all through lifecycle of the medical device, in accordance withContinue reading “Periodic Safety Update Report (PSUR)”