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1. [Comparison of the software safety evaluation methods in medical devices].

Author

Yu S, Pan Y, Yu X, and Zhu Y

Subjects
China, Europe, Quality Control, United States, Equipment Safety methods, Safety Management methods, Software
Abstract

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.

Published
2010

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