Medical Devices Regulatory Affairs

Degree:
Location: Anywhere

Why Medical Device Regulatory Affairs?

The Graduate Certificate in Medical Devices Regulatory Affairs provides an in-depth knowledge of the regulations and standards, global applications, and social impact of the medical device industry.

The Graduate Certificate in Medical Devices Regulatory Affairs online program presents an in-depth review of regulations relating to the development of medical devices, including those products not specifically regulated by federal law. Working and collaborating online, students will conduct a practical, in-depth analysis on how emerging developments and trends are reshaping the regulation of medical devices in the U.S., as well as reviewing global markets and regulations. This graduate program also examines related legal issues such as intellectual property, patents, and licensing, and considers the social and financial impact of the medical devices industry on the aging population.


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Unique Features


What you'll study

General Requirements

Graduate Certificate in Medical Devices Regulatory Affairs Core Requirements
RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00

Medical Devices Regulatory Affairs Electives

Complete two of the following:

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6211 - Combination Products and Convergence
4.00
RGA 6112 - Biomedical Intellectual Property Management: Patents
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6370 - Regulatory Writing: Medical Device Submissions
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00

Did You Know?

Nearly all RASI professionals (99%) have university degrees, and 69% have pursued postgraduate studies (RAPS, 2014).

 

Stackable Certificate

Credits earned completing this certificate can be applied towards the MS in Regulatory Affairs.

 

Average Time to Completion

1-1.5 Years

Commitment

Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Visa Eligible

No