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.

Required Courses

RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6205Emerging Trends and Issues in the Medical Device Industry4
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2

Medical Devices Regulatory Affairs Electives

Complete one of the following:4-5
The Business of Medicine and Biotechnology
Combination Products and Convergence
Biomedical Intellectual Property Management: Patents
European Medical Device Regulations
Japanese Medical Device Regulations and Registration
Canadian and Australian Medical Device Regulations
Emerging Medical Device Markets
Food, Drug, and Medical Device Law: Topics and Cases
Regulatory Writing: Medical Device Submissions

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required