FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot
Medtech's Next Top Maturity Model
• By Shawn M. Schmitt
US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.
CMMI Institute is busy training and lining up applicants to be part of teams to assess the capability and maturity of medical device firms under a burgeoning US FDA pilot that looks to elevate product, manufacturing and process quality.
In fact, the agency's
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