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Medical Devices / Regulatory Affairs

Improved Cross-Manufacturer Product Quality Data Needed, MDIC Finds

Oct. 19, 2016

Medical device manufacturers need access to quality benchmarking data and related FDA guidance to improve their products, says a new report from the Medical Device Innovation Consortium.

The report advocated three long-term goals: third-party adoption and development of analytics across seven quality areas; acceptance and use of the quality criteria; and the creation of ways to provide quality feedback to manufacturers.

The report is a product of the Case for Quality Initiative, a multiyear effort launched by the FDA to develop best practices, standards, tools, and metrics to improve product and manufacturing. — Jeff Kinney

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