This presentation describes the methods involved handing complaints. It presents two cases that might arise in dealing with servicing and follows them through the interlinked processes required by the FDA. This includes Complaints, CAPA, Medical Device Reporting, Corrections & Removals, Design Changes, and Risk Management.
The information distinguishes between records the manufacturer is required to maintain and reports that must be submitted to the FDA. Reports are characterized by the event that triggers the report, the allowed time to report, and the report’s contents. Records are characterized by the event that creates the record and the record’s contents.