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RAS 625. Regulatory Routes to Market: PMA's

Credits: 3
Department: Regulatory Affairs
Description: U.S. route to market for high risk medical devices, Pre-Market Approval Application (PMA) and Pre-Market Approval regulation and requirements. Best practices associated with the preparation and approval of PMAs. Developing regulatory strategies for markets.
Prerequisites: RAS 621
Semester Offered: DEMAND
Grading Method: ABCDF







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