Essentials of European Medical Device Regulatory Affairs

Module 8

Post Market Surveillance, Vigilance and FSCA

125

PMS What is Post market surveillance?

PMS is a manufacturers system for gathering data which relates to the quality, usefulness, performance, function, compatibility etc., of their products in the post market phase, analysing that data and using it to correct problems or address opportunities for improvement throughout the product lifecycle. It often includes activities such as:- • Complaints Management • Vigilance • Customer satisfaction surveys • Literature review • User group feedback sessions

126