This course has been designed to understand European directives, CE marking and guidance documentation.
Participants will understand EU directives and related directives (objectives, history, structure, purpose).
Who Should Attend?
The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), medical device manufacturers who desire to export to Europe.
Medical Device background, those in quality / regulatory affairs responsible for preparing / working with CE Marking Audits, those in U.S. and Canadian organizations that are new to the European Union market; those performing risk analysis / design for medical devices (development); and those companies in preparation of their own private label of medical device (marketed in Europe).
Please Note: Price includes materials, and certificate of attendance
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