Kim Kaplan, Program Manager
Conference Track: CMMI in the Healthcare Industry
Leveraging the internationally recognized framework of the Capability Maturity Model, medical device organizations are periodically assessed to determine their process capabilities and how they are continually improving the quality of their processes, systems and products. As part of being involved in the maturity model program, enrolled organizations are eligible for a set of regulatory benefits from the FDA. The CDRH Voluntary Medical Device Manufacturing and Product Quality pilot was announced in the Federal Register on July 25, 2017, with execution starting for early adopters of the program in Q4 of 2017.