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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(nèi)審員培訓服務簡介 ISO13485：2016《醫(yī)療器械質(zhì)量管理體系用于法規(guī)的要求》標準，是應用于醫(yī)療器械專用的獨立標準，強調(diào)滿足醫(yī)療器械法規(guī)要求，隨著歷史的發(fā)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(fā)布。國家食品藥品監(jiān)督管理局已按等同采用的原則轉(zhuǎn)化為行業(yè)標準YY/T0287-2016。在歐洲歐洲市場上醫(yī)療器械生產(chǎn)廠商被強制要求通過認證機構(gòu)的CE認證。 Time:2018-6-29 11:39:45 View:2832