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RAS 627. Intl Regulatory Affairs: European Union, East Europe, Australia & Canada

Credits: 3
Department: Regulatory Affairs
Description: International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada Regulatory requirements. Classification, marketing submissions, and pre- and post-market approval requirements. Regulatory strategies for global market introduction and planning for the challenges of global regulation.
Semester Offered: DEMAND
Grading Method: ABCDF

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