Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in Medical Devices, MS

The medical devices regulation concentration within the master’s degree for drugs, biologics, and medical devices program enables students to focus specifically on regulatory issues associated with global commercialization of medical device products and services. Medical device regulation, in many aspects, differs substantially from regulation of drug and biologic product commercialization. In addition to significant geographic variability between these product groups from a regulatory perspective, most of the regulatory operational functions associated with commercializing medical device products and services are unique to that product category. Moreover, these differences extend to both the preapproval and postapproval aspects of compliance reporting between the two sets of product groups. Given this variability, the medical devices regulation concentration gives students the opportunity to study the global regulatory marketing approval processes, compliance issues, and operational details specific to this product group. The concentration also enables students to compare and contrast both the similarities and differences between global medical device product and service regulations and those of drug and biologic product regulation.

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6203Pharmaceutical and Medical Device Law: Topics and Cases5
RGA 6370Advanced Regulatory Writing: Medical Device Submissions4
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Electives

Complete 22 quarter hours from the following. At least one elective must be taken from each of the categories below. 22
Regulatory and Clinical Operations
Application of Quality System Regulation in Medical Device Design and Manufacturing
Drug and Device Supplier Risk Management: Compliance and Processes
Regulatory Perspective: Product Development, Business, and Strategy
Advanced Topics in Advertising and Promotion of Drugs and Medical Devices
Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
Emerging Trends and Issues in the Medical Device Industry
Strategic Planning and Project Management for Regulatory Affairs
Combination Products and Convergence
Personal and Career Development (Enrollment in COP 6940 requires participation in the cooperative education program, subject to availability)
Integrative Experiential Learning
Interdisciplinary Foundations
International
European Medical Device Regulations
Japanese Medical Device Regulations and Registration
Canadian and Australian Medical Device Regulations
Emerging Medical Device Markets
Working in Multicultural Environments: Challenges and Opportunities
Medicines Regulatory Harmonization in Africa
Special Topics
Medical Device Product Development in Canada
Intellectual Property in the Life Sciences
Global IVD Regulations Submissions
Preparing EU Medical Device Clinical Evaluations

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required