医疗器械不良事件监测与风险管理

The Risk Management and the Adverse Events Monitoring of Medical Devices

医疗器械不良事件监测是控制产品风险的主要手段。本文分析了医疗器械产品研发、生产、使用阶段的风险来源,提出了风险控制的措施,并就如何进一步加强医疗器械不良事件监测,提高风险管理能力提出了建议。

Adverse events monitoring is the primary means to control the risks of medical devices. Through analyzing the risks produced in R＆D, production and use of medical devices, this paper brings forward the measures to control risks, and gives advises to improve the adverse events monitoring of medical devices and the ability of risk management.