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FDA CfQ Pilot Program

The FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) explores the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture.

The program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden to show quality, and assurance of safety and effectiveness in product development and manufacture. 

More information about the CfQ Pilot Program is available at www.federalregister.gov.

Here’s what AdvaMed members in the CfQ Pilot Program have to say about it: 

“The maturity assessment provided us with an evaluation of the health of our operations, engaging individuals most familiar with our day-to-day work.  The assessment helped us identify strengths and weaknesses and opportunities for further consideration.  As important, the assessment helped us develop operational excellence metrics that will measure the continuous execution and quality oversight of our processes.  Now, a cross-functional team is exploring how we can capitalize on what we learned to further advance our processes and our ability to provide world-class products and services to our customers.”

– Kathie Bardwell, Senior Vice President & Chief Compliance Officer, STERIS Corporation

“Participating in the pilot program helped us identify and launch quality improvement efforts.  At the root of these efforts is our objective to improve product quality and service to our physicians and patients.  The most surprising and positive aspects of the assessment were how little time and effort it took compared to a regulatory audit, engaging and interactive discussion with the assessors about how work is performed (unlike the lengthy document review typical of regulatory inspections), and the result:  identification of significant ways to improve product and process quality, not just comply with regulations.”

– Al Crouse, Senior Quality Director, CVRx