Comparison of the software safety evaluation methods in medical devices
Yu, S.; Pan, Y.; Yu, X.; Zhu, Y.
Zhongguo Yi Liao Qi Xie Za Zhi 34(5): 360-364
2010
ISSN/ISBN: 1671-7104 PMID: 21179714 Document Number: 647706
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 U.S. and Europe.
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