[Discussion about the application of risk management to medical devices].
Safety and effectiveness of medical devices is a focus of people's attention, which is also a central work for the government's administration. Carrying out safety standards of medical devices, implementing the quality system standards and risk management standards are supplemented with each other. The risk management is an indispensable part to the quality management system of medical devices.
Xu
Feng-Ling
FL
Shanghai Drug and Medical Device Evaluation Center, Shanghai 200021.
D019544:Equipment Failure Analysis; D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods; D018570:Risk Assessment; D012307:Risk Factors; D012308:Risk Management; D017751:Safety Management