Re-inventing Quality assurance for Medical Devices

• By: Dev Raheja, Design Assurance Consultant
• Date: December 08, 2011

Usually Quality Assurance (QA) is looked upon as bearers of bad news. Then it is forced react with the CAPA (Corrective and Preventive Action) system which is always reactive. Instead, QA can be the bearers of good news by reporting which adverse events were proactively prevented by eliminating their root causes. This article, by renowned medical devices expert Dev Raheja, details the ways this can be achieved.