Northeastern University campus

Health Sciences

Graduate Certificate in Medical Device Regulatory Affairs at Northeastern University

Northeastern University, United States

Programme overview

The Graduate Certificate in Medical Device Regulatory Affairs allows students to gain a detailed knowledge of the regulations influencing the commercialization of new and existing medical devices. The intensely practical curriculum spans the entire product development life cycle and introduces students to the salient features governing both pre- and postapproval stages. Offered at: Boston, Online.

Faculty: College of Professional Studies  |  Department: Graduate Certificate Programs  |  Duration: 12 semester hours  |  Study mode: full-time  |  Location: Boston, MA, United States

What you will study

Requires 12 semester hours. Required courses include RGA 6610 Introduction to Food and Drug Administration Medical Device Regulation; RGA 6620 Medical Device Development: A Regulatory Overview; RGA 6630 Medical Device Quality Management System: Principles and Applications; RGA 6640 Risk Management: Compliance and Processes.

Official programme page

Application information

Tuition is charged per credit, so the total depends on the modules you register for each year. Current fees are listed in the official fee schedule.

Duration: 12 semester hours

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