The Capability Maturity Model Integration  (CMMI) has been successfully applied for process improvement in various product development environments for almost 10 years, with its predecessor, the Software Capability Maturity Model (CMM-SW) used successfully in the 1990’s. The Software Engineering Institute has provided reports on the successful use of the CMMI in aerospace, defense, government, financial, and insurance industry sectors. Little is known of adoption in medical device engineering.

This paper summarizes the comparison performed between the CMMI and the regulations and standards that drive software intensive medical device product development. The primary perspective is for medical device software engineering, where the most significant opportunity lies. This paper shows what is missed when medical device engineering teams chase ISO 13485 and IEC 62304 compliance without using CMMI to effectively manage processes.

The CMMI to IEC 62304 Mapping is provided at the end of this paper.