What is CAPA? Corrective and Preventive Action (CAPA) is a fundamental quality process for medical device manufacturers including SaMD. From the regulations it is really not that complicated. 21 CFR 820.100 reads: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1)...Read More
When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun. Often this is due to the nature of research itself - one is exploring a concept or design approach that may or may not pan out in the end. The US...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.