| 风险管理在医疗器械中应用的探讨 |
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| 引用本文： | 徐凤玲. 风险管理在医疗器械中应用的探讨[J]. 中国医疗器械杂志, 2006, 30(2): 123-128 |
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| 作者姓名： | 徐凤玲 |
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| 作者单位： | 上海市药品和医疗器械审评中心,上海,200021 |
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| 摘 要： | 医疗器械安全有效是人们关注的焦点，也是政府实施监督管理的核心，贯彻产品安全性标准、实施医疗器械质量体系标准和医疗器械风险管理标准，是相辅相成互为补充的，风险管理是医疗器械生产企业质量管理体系中不可缺少的组成部分。
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| 关 键 词： | 风险管理 质量管理 医疗器械 |
| 文章编号： | 1671-7104(2006)02-0123-06 |
Discussion about the Application of Risk Management to Medical Devices |
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| XU Feng-ling. Discussion about the Application of Risk Management to Medical Devices[J]. Chinese journal of medical instrumentation, 2006, 30(2): 123-128 |
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| Authors: | XU Feng-ling |
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| Affiliation: | Shanghai Drug and Medical Device Evaluation Center, Shanghai 200021. |
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| Abstract: | Safety and effectiveness of medical devices is a focus of people's attention, which is also a central work for the government's administration. Carrying out safety standards of medical devices, implementing the quality system standards and risk management standards are supplemented with each other. The risk management is an indispensable part to the quality manaqement system of medical devices. |
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| Keywords: | risk management quality management medical device |
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