[Risk management for medical devices].
Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.
Xie
Ying-jie
YJ
Jiangsu TUV Product Service Ltd., Shanghai Branch, MHS Department, Shanghai, 200020.
Xu
Xing-gang
XG
D004864:Equipment and Supplies / Q000592:standards*; D007221:Industry / Q000592:standards; D012308:Risk Management