Medical device manufacturers must record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident. As a result, companies must implement best-of-breed complaint handling systems that enable them to implement enterprise complaint management coupled with medical device complaint reporting processes.
Sparta Systems' complaint management software and regulatory reporting compliance software enables organizations to implement an effective, consolidated, global approach to managing customer complaints and regulatory reporting, including electronic reporting methods such as eMDR and eMDV.
Sparta Systems' regulatory reporting and complaint management software facilitates compliance, reduces product safety risk and streamlines workflow processes. Sparta’s software solution integrates complaint handling and medical device reporting into the overall quality management system, giving users the benefit of a single, familiar interface and eliminates the need for complex and costly custom complaints software integration.