Research on Medical Device Software Development and Design Based on CMMI Model

Abstract

In order to the problem of poor portability and confusion in management of medical device software, the Capability Maturity Model Integration (CMMI) is applied to optimize the design and development process of medical device software. IEC 62304 is used as a software development standard to improve the software process capability. Firstly, this paper makes a detailed comparison between medical device software and other application software. On this basis, the timing of CMMI implementation and the process of risk management improvement are studied and discussed. Then the interface framework of CMMI process area and IEC 62304 was obtained and the optimized flow of two domains in risk management was reasonably used in the evaluation process. The software portability based on CMMI has been significantly improved, and the management level is clear. The deviation rate of each stage is less than 10%. The simulation result shows that in the field of medical device software research and development, CMMI can be used and optimized, so as to improve software process capability.

Keywords

• medical device software
• capability maturity integration model
• iec 62304
• process area
• risk management