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FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

Executive Summary

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

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