Study on the Construction of a Post-Market Quality Risk Prevention and Control Index System for Medical Devices from the Perspective of Intelligent Regulation
Study on the Construction of a Post-Market Quality Risk Prevention and Control Index System for Medical Devices from the Perspective of Intelligent Regulation
With the ongoing expansion of China's medical device industry and continuous product innovation,higher demands have been placed on supervision,risk prevention,and control.Risk management has become a key element in ensuring the quality and safety of medical devices.This study summarizes key points of medical device risk prevention and control monitoring by analyzing literature and policies related to domestic and international medical device regulation and risk management theories,as well as integrating the framework and information data from the Chengdu Intelligent Regulation Platform for Medical Devices.From the perspective of intelligent regulation,a quality risk prevention and control index system for medical devices was established.This system can assist regulatory agencies in identifying quality and safety risk points,reducing the difficulty of risk identification,and forecasting key areas for medical device inspection,testing,and supervision.It aims to provide a reference for establishing and improving mechanisms for identifying,assessing,and issuing warnings about medical device quality risks.
关键词
医疗器械/监管/质量风险/风险防控/指标体系
Key words
medical devices/regulation/quality risk/risk prevention and control/index system
维普
万方数据