Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling on quality system is meaningful when complaints are thoroughly analyzed and investigated.
Helps in correcting flaws
Complaints serve as a great means for making manufacturers of medical devices understand the problem at its root. It is this understanding that will help them to come up with solutions to these problems. Having an effective complaint handling on quality system in place is an FDA requirement from a medical device manufacturer. Complaints are the platform from which to evaluate, investigate and analyze the device and later take corrective action.
To facilitate effective complaint handling on quality system; the FDA has a mechanism. Called the Medical Device Reporting (MDR); this system is meant for receiving medical device adverse events from manufacturers, importers and user facilities. This mechanism helps in quick detection and correction of adverse events. User Facilities (e.g., hospitals, nursing homes) need to report suspected medical device related deaths to both the FDA and the manufacturers.