Medical Devices Regulatory Affairs

Degree:
  • Certificate
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.


More Details

Unique Features


What you'll study

General Requirements

Graduate Certificate in Medical Devices Regulatory Affairs Core Requirements

Required Courses

RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00

Electives

Complete the appropriate number of electives to obtain minimum quarter hours required for the program:

BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6002 - Regulatory Compliance Culture
2.00
RGA 6112 - Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
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 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6242 - Preparing EU Medical Device Clinical Evaluations
2.00
RGA 6243 - Medical Device Product Development in Canada
4.00
RGA 6370 - Advanced Regulatory Writing: Medical Device Submissions
4.00
RGA 6420 - Global IVD Regulations and Submissions
4.00
ITP 6305 - Technology Licensing
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

Meets F-1 Visa Requirements

No