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9 Device-Makers Wanted For US FDA Pilot Program To Measure Quality System Maturity

 
• By Shawn M. Schmitt

US FDA is looking for nine medical device firms to enroll in its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which will use third-party Capability Maturity Model Integration (CMMI) appraisers to evaluate a company's quality system maturity as a view into whether it is operating above a compliance baseline.

CMMI CODE BINARY

US FDA is seeking nine medical device manufacturers to participate in a pilot that will use third-party Capability Maturity Model Integration (CMMI) appraisers to measure the maturity of their quality systems and manufacturing processes.

The Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, offered by the agency in conjunction with the Medical Device Innovation Consortium (MDIC), will run from Jan. 2-Dec. 28, 2018, according to an

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