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

Executive Summary

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.

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