Developing a configuration management capability model for the medical device industry

Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) is achieved. This paper outlines the development of a Configuration Management Capability Model (CMCM). The CMCM is a Software Process Improvement (SPI) model specifically dedicated to Configuration Management (CM) for the medical device industry. This paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration (CMMI®) CM process area. 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 (MDR) guidelines.