| 医疗器械不良事件监测与风险管理 |
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| 引用本文： | 焦灵利. 医疗器械不良事件监测与风险管理[J]. 中国医疗器械信息, 2008, 14(12): 37-40 |
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| 作者姓名： | 焦灵利 |
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| 作者单位： | 江苏省食品药品监督管理局认证审评中心,南京,210002 |
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| 摘 要： | 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。
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| 关 键 词： | 不良事件 监测 风险管理 |
The Risk Management and the Adverse Events Monitoring of Medical Devices |
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| JIAO Ling-li. The Risk Management and the Adverse Events Monitoring of Medical Devices[J]. China Medical Devices Information, 2008, 14(12): 37-40 |
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| Authors: | JIAO Ling-li |
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| Affiliation: | JIAO Ling-li( Center for Certification ＆ Evaluation, JSFDA (Nanjing 210002)) |
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| Abstract: | 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. |
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| Keywords: | Adverse Events Monitoring Risk Management |
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