Northeastern University College of Professional Studies
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Graduate Certificate In Medical Devices Regulatory Affairs

The Graduate Certificate in Medical Devices Regulatory Affairs will provide 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.
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The medical device industry has continued to experience a 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 will provide 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 also review the global applications of the medical device industry. Students will conduct practical, in-depth analyses on how emerging developments and trends are reshaping medical devices regulation in the U.S. The program will also be concerned with 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.
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