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ISO13485 (YY/T0287) 內審員培訓服務簡介 ISO13485：2016《醫療器械質量管理體系用于法規的要求》標準，是應用于醫療器械專用的獨立標準，強調滿足醫療器械法規要求，隨著歷史的發展，ISO組織將此標準進行了修訂，升級為ISO13485：2016于2016年7月15日發布。國家食品藥品監督管理局已按等同采用的原則轉化為行業標準YY/T0287-2016。在歐洲歐洲市場上醫療器械生產廠商被強制要求通過認證機構的CE認證。 Time:2018-6-29 11:39:45 View:2878

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