开展医疗器械不良事件监测和报告工作是十分重要的。
It is important to carry out the work of monitoring and reporting the adverse events of medical instruments.
目的：初步探讨医疗器械不良事件监测和风险管理的概念和方法。
OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent .
医疗器械不良事件监测是确保上市医疗器械安全有效的重要手段之一。
Medical device adverse event monitoring is one of the most important methods to guarantee the safety of post-marketing products.
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