Complete all courses and requirements listed below unless otherwise indicated.

Core Requirement

Required Courses
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
Electives
Choose from the following:6
Emerging Trends and Issues in the Medical Device Industry
European Medical Device Regulations
Medical Device Product Development in Canada
Product Development and Process Validation
Advanced Regulatory Writing: Medical Device Submissions

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required