国际医疗器械安全性信息适时监测和分析研究 - docin.com豆丁网 FDA监测上市后医疗器械的安全 信息主要来源是医疗器械不良事件报告等的报告 系统,其主要包括: a、医疗器械不良事件报告(Medical Device Reporting ,MDR),该系统是用于FDA接收来自 制造商、销售商和器械使用医疗机构的严重医疗 器械不良事件的强制报告系统
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医疗器械不良事件报告覆盖范围窄,质量有待提高。
The scope that the reports covered is narrow and the quality needs to be raised.
针对辖区内医疗器械不良事件报告率低的现象,结合现行的监测管理模式,查找并分析原因。
Focusing on the phenomena that the reported adverse event of medical device is quite low, we use the method to analyze the cause on the base of actual monitoring management.
结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。
Results Management of medical devices for safety and quality is to be achieved by means of reports of adverse events, recall and follow-up of medical devices.
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