R A 773 - Medical Device Regulations

Units: 3

Prerequisite(s): R A 602.

Introduction to regulatory affairs requirements for the medical device industry through stages of product development. FDA medical device regulations, terminology, timelines, and actual steps followed by regulatory affairs professionals. Commercial, operational, and strategic aspects of the regulatory approval process for in vitro diagnostics (IVD) and medical devices. Marketing, regulatory intelligence, risk management, and strategic considerations Maximum Credits: combined credit six units of Regulatory Affairs 773 and R A 774 applicable to a master’s degree.

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