December 3, 2019

MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from MDIC, the medical device industry, strategy consultants, and the FDA, including a proposed framework for risk-based improvement.

Download the whitepaper here.