Northeastern’s 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.

Through a targeted curriculum, this certificate program reviews the global applications of the medical device industry. You and your classmates will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S. This program also features insights on the social and financial impact of the medical devices industry on an aging population.

The certificate will help advance the careers of students coming from such fields as bioengineering, quality control/assurance, intellectual property, business, and marketing. Courses are selected to make this certificate ideal for students already working in the regulatory world or those just entering the profession.

Program objectives

• Familiarity with the regulations and standards that apply to the development of medical devices, within the US and globally
• To conduct a practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S.
• Understand the social and financial impact of the medical devices industry on the aging population.

Unique Features

1. Classes available online or at the Boston campus for maximum flexibility
2. Choose from elective courses that cover a broad range of practical and relevant issues in the medical device field
3. Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs