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Registration Service of Medical Devices: CRC services Medical Device Business License Medical Device Registration Contract Research Organization ISO 13485 Quality System Certification GMP CE Certification Service FDA Registration (Filing) Software Integrity Verification Service Production process validation service ISO 15378 Medical Package System Certification ISO 13485 Internal Auditors Training Regulatory Services For Medical Devices
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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:2518