Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
July 16 & 17, 2012
The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary elements in addressing the essential requirements, technical dossiers, declarations of conformity and the six steps required for manufacturers to market medical devices in the European market.
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