April 20, 2020

MDIC | Kathryn Merrill, CAPA Process Improvement Program Chair

This past year the Medical Device Innovation Consortium (MDIC) facilitated a collaborative effort of the medical device industry, strategy consultants, and the Food and Drug Administration (FDA) to bring together cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) process as a continuous improvement process.  The intent was to design a less burdensome process that would also drive higher product quality. The associated white paper summarizes initial findings and recommendations, including a proposal for a risk-based improvement framework. Currently MDIC is looking for firms ready to test the framework in a live pilot.  If your organization is interested, contact Alan Baumel – MDIC Case for Quality Program Director (abaumel@mdic.org)