Exploration on Application of CMMI for Development Process of Medical Device Software
- VernacularTitle:应用CMMI探讨改进医疗器械软件研发流程
- Author:
Yan FENG
- Publication Type:Journal Article
- Keywords:
medical device software;
CMMI;
IEC62304;
PA;
risk management
- From:
Chinese Medical Equipment Journal
2004;0(08):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To correctly apply the Capability Maturity Model Integration(CMMI) model to the development process of medical device software,thus optimizing and improving the development process and enhancing the software process capability.Methods The matching between CMMI and IEC62304 was analyzed.The compatibility on application was investigated by taking risk management(the core process) as an example.Results The interface between CMMI and IEC62304 was discovered as well as their optimized process in risk management.Conclusion The process of medical device software development not only can be improved by CMMI model,but also should be.
