摘要
目的:将能力成熟度整合模型(Capability Maturity Model Integration,CMMI)的改进模式合理应用到以IEC62304作为依据标准的医疗器械软件开发中,改进和优化研发流程,提高软件过程能力。方法:分析两者的关系与接口问题,研究二者之间的兼容性和在实施层面上的匹配性,并以核心过程——安全与风险管理为例来进行实施。结果:得到了CMMI过程域和IEC 62304的接口框架以及二者合理并用后在风险管理这个域中的优化流程。结论:医疗器械软件研发领域能够使用而且应该使用CMMI对其过程进行优化,从而提高软件过程能力。
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.
出处
《医疗卫生装备》
CAS
2008年第8期27-29,共3页
Chinese Medical Equipment Journal
