A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR.
By Bob Mehta
I have always experienced great difficulty in trying to fathom why medical device manufacturers fail to invest in developing effective approaches for complaint management. After all, when a customer calls to complain, the information garnered as part of the complaint process can be used to strengthen the organization as a whole, improving the product performance and the quality management system (QMS).
In the U.S. medical device industry, not only is the effective handling of complaints warranted, it is mandated by FDA, with the requirements delineated within the agency’s quality system regulation (QSR). For those of you...