医疗器械软件常见认识误区解析

Analysis of Common Misunderstanding on Medical Device Software

当前业内对于医疗器械软件存在很多认识误区,因此有必要对常见的、关键的认识误区进行解析。本文针对软件定义、软件风险、软件质量与缺陷、软件变更与版本、现成软件的认识误区进行了讨论和分析,以便统一业内认识。

There are a lot of misunderstandings on medical device software in the medical device industry at present, so it is necessary to analyze the common and key misunderstanding on medical device software. The misunderstanding of software definition, software risk, software quality and defect, software change and version, off-the-shelf software had been discussed and analyzed in order to unify the industry understanding on medical device software.