Medical Devices Regulatory Affairs, Graduate Certificate

The national and regional medical device industries have continued to experience significant market growth, despite the fluctuations in the overall global economy. There are more than 7,000 medical device companies in the United States alone, and nearly 1,000 of these are based in Massachusetts. In total, the medical device sector in Massachusetts employs 36,000 workers, has a payroll of over $1.8 billion, and annual product shipments of $7.3 billion.

The Graduate Certificate in Medical Devices Regulatory Affairs provides students with an opportunity to gain a detailed knowledge of the regulations influencing the commercialization of new and existing medical devices. The intensely practical curriculum spans the entire life cycle of product development and introduces students to the salient features governing both pre- and postapproval stages. The program content also examines the relationship between regulatory agencies and the medical device industry. Students have the opportunity to take specialized courses on regulatory systems outside the United States.

The certificate will help advance the careers of students coming from such fields as bioengineering, quality control/assurance, intellectual property, business, and marketing. The choice of several courses makes this certificate ideal for students already working in the regulatory world as well as those just entering into the profession.

Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Complete all courses and requirements listed below unless otherwise indicated.

Core Requirement

Required Courses
RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2
RGA 6202Medical Device Development: A Regulatory Overview4
Complete the appropriate number of electives to obtain minimum quarter hours required for the program:10-12
Human Experimentation: Methodological Issues Fundamentals
The Business of Medicine and Biotechnology
Regulatory Compliance Culture
Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
Emerging Trends and Issues in the Medical Device Industry
European Medical Device Regulations
Japanese Medical Device Regulations and Registration
Canadian and Australian Medical Device Regulations
Emerging Medical Device Markets
Application of Quality System Regulation in Medical Device Design and Manufacturing
Preparing EU Medical Device Clinical Evaluations
Medical Device Product Development in Canada
Advanced Regulatory Writing: Medical Device Submissions
Global IVD Regulations and Submissions
ITP 6305

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required