Quality Assurance Model For Medical Device Software Based On CMMI

This article established a quality assurance model, which is based on Capability Maturity Model Integration(CMMI) and characteristics of the industry,applied to the medium size medical device software companies.The model can improve the maturity of software engineering and also the medical device software quality. The quality assurance model consists of three sub-models, respectively, project management model, engineering model and supportive management model. The three models are based on the specific goals and specific practices of 13 different process areas from CMMI, and developed a complete implementation for medical device software organizations. Finally, the advantages and disadvantages of this model are summarized, and recommendations are provided.