This pilot study is a collaboration of medical device manufacturers, MDIC, and the FDA to recast the Corrective and Preventive Action (CAPA) process as a least burdensome continuous risk-based improvement process to improve product quality and patient safety.
An online training course was developed to provide users with a high-level overview of the proposed CAPA process, including insights for auditors.
Additionally, a pamphlet was developed to provide a high-level overview of the proposed CAPA process for those organization interested in participating in the live pilot. View the pamphlet below or download an online version.
