Purpose of Document
Once a medical device has been approved for supply it is necessary to make sure that the product continues to meet all regulatory, safety and performance requirements and standards that were required for the approval.
ISO 13485:2016, the Quality System Regulation (21 CFR Part 820.198), Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro medical devices (IVDR) require medical device companies to establish and maintain procedures for receiving, reviewing and evaluating feedback and complaints as a means of monitoring quality, performance and safety requirements.
You are committed through your (Quality) Management System, to meeting its customer’s expectations and requirements.
