Developing a configuration management model for use in the medical device industry

This paper outlines the development of a Configuration Management model for the MEDical device software industry (CMMED). The paper details how medical device regulations associated with Configuration Management (CM) may be satisfied by adopting less than half of the practices from the CM process area of the Capability Maturity Model Integration (CMMI). It also investigates how the CMMI CM process area may be extended with additional practices that are outside the remit of the CMMI, but are required in order to satisfy medical device regulatory guidelines.