Complaint Investigation is an essential regulatory requirement for medical devices as part of complaint handling process. Complaint Investigators are facing various problems like lack of information to identify the actual root cause. Effective complaint investigation methodology can help medical device manufacturers to identify the actual root cause of various problems faced by the peoples across globe and to sustain their products in the market for a longer duration. Complaint Investigation and its identified root cause serve as a source of insights on what areas should be worked on and upgraded. The importance of setting up a dedicated complaint Investigation along with complaint handling unit has been realized, and manufacturers have now started paying more attention to this area. With the use of proper investigation process, manufacturer can identify the proper corrective and preventive actions, quality of the supplier products, and re-assess the risk by identifying proper root cause and it helps to prevent the recurrence of the issue.
An effective complaint management system provides proper documentation for the investigation process and allows companies to link complaints to corrective actions, supplier quality, and provides the ability to re-assess the risk by identifying proper root cause and preventing recurrence of the issue and further customer complaints. Download this whitepaper to continue reading.