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