[Exploration on the regulation mode of medical device quality and safety on a life-circle basis].
A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.
Yu
Hong-Liu
HL
University of Shanghai for Science and Technology, Shanghai 200093.
Qian
Xing-San
XS
D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D008962:Models, Theoretical; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011786:Quality Control; D017751:Safety Management