RAS627
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Intl Regulatory Affairs: European Union, East Europe, Australia & Canada
Prefix
RAS
Course Number
627
Course ID
00137412-2023-03-15
Course Level
Graduate
Instructional Type
Lecture
Grade Type
A-F Only
Department/Unit(s)
College/School
College of Business, Engineering, and Technology
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.