Program Details

Designed to provide students with an understanding of medical device regulation and the industry's software development.
Boston, United States
Program Type:
Full Degree
Degree Level:
Graduate Certificate

Program Overview

Program Description:
As biotechnology, pharmaceutical, and medical device companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of medical device regulation and the industry's unique software development and validation issues. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words in which FDA has applied its own distinctive meaning. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Additional Program Information

New England Association of Schools and Colleges, Commission on Institutions of Higher Education
FinancialAid Info:
Yes, all students are encouraged to apply for financial assistance when they apply for admission. Please speak to an Enrollment Advisor for more information.

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