bypipefittings.com
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justop-cn.com
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产品展示-Solar connector/solar light-JUSTOP
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easyconns.com
spirit level-ZHEJIANG ECONNS INDUSTRY CO., LIMITED
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medevicechina.com
美国FDA QSR820质量体系 - 美德思国际医疗器械咨询机构 MEDevice Services, LLC
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美国 英国 日本 北京 上海 深圳 成都. FDA QSR820也叫QSR (Quality System Regulation) ,是21 CFR 820的一种简易叫法。 美国国会是法律的制定机构.其制定的 联邦食品药品和化妆品法案(Federal Food, Drug and Cosmetic Act) 是美国关于医疗器械管理的最高法律性文件。 其中21CFR820是FDA根据 联邦食品,药品和化妆品法案 第501、502、 510、 513、 514、 515、 518、 519、 520、 522、 701、 704、 801、 803条款的授权而制定的规范医疗器械企业质量体系要求的法规,即Quality System Regulation,简称QSR或QSR820。 21QSR820.1规定,所有在美国和波多黎各境内的,或者有产品出口到美国和波多黎各境内的医疗器械企业必须按QSR820的要求建立质量体系。 2) 根据审核结果提出整改意见,并完善现有的体系,达到FDA QSR 820的规定.