摘要
当前软件版本在医疗器械软件监管中的作用未引起足够重视,首先讨论了软件版本的监管作用,然后基于业内对于软件版本认识误区的讨论分析了软件版本监管的必要性,最后针对软件版本命名规则的设定、软件组件的版本监管和软件版本的监管方案提出了具体工作建议。
The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.
出处
《中国医疗器械杂志》
CAS
2015年第1期48-50,共3页
Chinese Journal of Medical Instrumentation
基金
国家技术支撑计划课题(2012BAI22B04)
关键词
医疗器械软件
软件版本
软件变更
软件监管
medical device software
software version
software change
software supervision
