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Medical Device Quality

Like FDA, AdvaMed believes that product quality goes beyond compliance with current quality regulations. Instead, our goal is to partner with FDA to find design, production, and distribution practices that enhance medical device quality. We work towards this goal through efforts that include supporting FDA initiatives and by developing and providing resources and training on key principles of device quality.

Case for Quality

AdvaMed supports FDA’s Case for Quality initiative. This initiative helps FDA identify device manufacturers that produce high-quality devices, as well as practices that support consistent quality manufacturing. To help drive the Case for Quality, AdvaMed launched its Case for Quality Library. This is a library of successful quality practices employed by AdvaMed Members. Quality professionals may use the library as a resource to strengthen their organizations’ quality performance. 

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FDA CFQ Pilot Program

AdvaMed supports FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program. This pilot program, which grew from the Case for Quality, explores a quality maturity appraisal, along with metrics and resource optimization, to improve patient safety and outcomes. AdvaMed members are participants in and endorse this program.

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Training Modules

AdvaMed offers training on quality-related topics. This training allows design, manufacturing, and quality professionals to understand and promote device quality. We leverage our members’ subject matter experts to provide this training. For example, we recently conducted training on software in devices and training on topics such as device sterility and regulation of IVD products is in development.

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