Dealing With Customer Complaints
The Quality System Regulation ( 21 CFR Part 820 ) requires medical device companies to establish and maintain procedures for receiving, reviewing, and dealing with customer complaints by a formally designated unit, as well as to maintain complaint files. There are similar requirements for ISO-certified medical device companies. ISO 9000 requires management to review feedback from customers, especially complaints. ISO 13485 requires the establishment of a procedure to gather feedback from customers as a way of monitoring quality.