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双循环
本文采用比较研究与调研分析相结合的方法，通过对比欧美国家对医疗器械软件上市前评价与上市方法，并实地调研分析上海市医疗器械生产企业对软件研发质量控制程序，分析医疗器械软件安全存在的问题，并对高风险医疗器械软件上市前的安全性评价进行了有益的探索。
<<The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in US and Europe.
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