An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers.
