The New Voluntary Program Concerning Quality System Maturity for U.S. Medical Device Manufacturers: A conversation with FDA and CMMI.
Through the collaborative efforts of the Medical Device Industry and FDA as part of the Medical Device Innovation Consortium (MDIC), a new Voluntary Program leveraging CMMI’s capability maturity model to evaluate medical device manufacturers’ quality systems level of maturity has been newly developed and ready for launch in January 2018. The Case for Quality initiative, launched in 2011, enables the FDA and the Medical Device Industry identify device manufacturers that consistently produce high-quality devices, help other manufacturers raise their level of quality, and promote practices that support consistent quality manufacturing and improved patient safety. Building a strong case for quality has far reaching impact across numerous stakeholders - industry, health care providers, patients, payers, and investors.
Please join Cisco Vicenty, FDA Program Manager - Case for Quality, Doug Grindstaff, CMMI Business Development Leader, and George Serafin
, Grant Thornton’s Life Sciences and Health Care leader, as they describe the new Voluntary Program and provide their collective thoughts and insights.
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