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Comparison of the software safety evaluation methods in medical devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation ; (6): 360-364, 2010.
Article in Chinese | WPRIM | ID: wpr-281083
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.
Subject(s)
Full text: Available Index: WPRIM (Western Pacific) Main subject: Quality Control / United States / Software / China / Safety Management / Equipment Safety / Europe / Methods Country/Region as subject: North America / Asia / Europa Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2010 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Quality Control / United States / Software / China / Safety Management / Equipment Safety / Europe / Methods Country/Region as subject: North America / Asia / Europa Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2010 Type: Article