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 medical device industry has continued to experience healthy market growth despite the sluggishness of the national economy. In fact, the industry's support of research and development efforts is expected to top $194 billion this year. There are over 7,000 medical device companies in the United States, 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 shipments of $7.3 billion.
The Graduate Certificate in Medical Devices Regulatory Affairs provides an in-depth knowledge of the regulations and standards that apply to the development of medical devices, including those products not specifically regulated by federal law. The program will review the global applications of the medical device industry. Students will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S. The program also focuses on the social and financial impact of the medical devices industry on the aging population.
- Boston location on flagship campus—a hub for healthcare, education, finance, business, biotechnology, and the life sciences
- Choose from elective courses that cover a broad range of practical and relevant issues in the field
- Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
What you'll study
Complete the appropriate number of electives to obtain minimum quarter hours required for the program: