Study on Implementation Approach for Standard YY/T 0316(ISO 14971) "Medical Devices-Application of Risk Management to Medical Devices"

Abstract

This thesis briefly introduced the risk management of medical devices and the development history of the standard "YY/T 0316 Medical devices-Application of risk management to medical devices".Through research on related literatures and standard questionnaire survey on medical devices’risk management,we knew the application status of risk management standard in medical devices home and abroad.Then we analyzed some problems in implementation of the standard,and at last we proposed the implementation approach and some suggestions to these problems to accelerate the implementation of the standard.