Category: Medical Devices

The Corrective and Preventive Action (CAPA) system is one of the most critical elements of a medical device quality management system. It is also one of the areas most frequently cited during regulatory inspections and quality audits. This article explores how to evaluate the effectiveness of your CAPA system through audit and what auditors look for when assessing CAPA…

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Quality audits are a critical component of medical device manufacturing, serving as both a regulatory requirement and a practical tool for ensuring product safety and quality system effectiveness. This guide covers everything medical device manufacturers need to know about quality audits, from regulatory requirements to practical execution. Why Quality Audits Matter in Medical Devices Medical devices directly impact patient…

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