MDR法规下MDR法规下骨科器械CE认证质量体系要求解读1MDR质量管理体系要求概述2MDR合规战略介绍主要内容3MDR质量体系GAP分析和相关程序文件详解4过渡期思考和对策1MDR质量管理体系要求概述1MDR质量管理体系要求概述Artile10制造商的义务,第9句:Manufacturersofdevices,otherthaninvestigationaldevices,shallestablish,document,implement,maintain,keepuptodateandcontinuallyimproveaqualitymanagementsystemthatshallensure...
MDR系列课程:欧盟MDR临床评估Regulation(EU)2017/745-欧盟MDR临床评估本课程要解决如下问题:⚫HowimportantisPMSforMDDinpreparationfortheMDR⚫在准备MDR认证过程中,如何认识MDD相关PMS的重要性?⚫WhatarethedifferencesbetweenMEDDEV2.7.1rev4andtheMDR?⚫MEDDEV2.7.1(Rev.4)和MDR的不同之处⚫Howshouldamanufacturerre-assesstheirclinicaldata?⚫制造商如何再评估自己的临床数据?⚫WherecanrelevantClinicalEvaluationinf...
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