TrackWise risk management functionalities enable companies to integrate risk management processes across their entire quality management system. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk using standards such as ISO 14971 – the international standard recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices. Additionally, this can trigger updates to review the product risk register to have a truly closed-loop process. TrackWise provides an enterprise risk management solution for medical device companies by offering a fully configurable platform to identify, measure, quantify and classify risk globally. This ensures that medical device manufacturers can focus their resources on the areas of highest risk, while continuing to monitor occurrences of lower-risk nonconformities.
"Prior to implementing TrackWise at Bovie Medical Corporation, we used a combination of paper-based and database systems, which served as repositories for data but were cumbersome to use and offered very little functionality. TrackWise is a completely scalable platform that allowed us to rapidly deploy applications without purchasing, installing, or customizing separate modules." "The breadth of its quality systems functionality and its user-friendliness resulted in a perfect fit for our users. The system was also well accepted by IT." - Bovie Medical Corp