Master of Engineering in Regulatory Biomedical Engineering

Regulatory Biomedical Engineering at GW

Program Overview

The Master of Engineering in Regulatory Biomedical Engineering (rBME) is an interdisciplinary program offered through the Department of Biomedical Engineering in partnership with GW's School of Medicine and Health Sciences. The new program addresses the need for a graduate program to train engineers in the specific set of skills of regulatory science, biomedical innovation, and entrepreneurship.

Students with training in engineering or physics and/or relevant industry/government experience study the fundamentals of biomedical engineering, global regulatory affairs, regulatory strategy in the development of devices and diagnostics, regulatory compliance, engineering patent law, medical measurements, and instrument design.

In addition to coursework, students gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.


The rBME program is 30 credit hours distributed across four areas:

  • Biomedical engineering coursework and practicum (12 credits)
  • Regulatory issues (9 credits)
  • Patent law for engineers (3 credits)
  • Targeted electives from various disciplines (6 credits)

‚ÄčStudents will require 12-24 months or 3 semesters for completion.¬†

Program Requirements

Program requirements and a list of approved coursework is maintained by the GW Bulletin:

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Program Outcome

Students who complete the Master of Engineering in Regulatory Biomedical Engineering acquire skill sets comparable to those of an engineer with five to seven years of experience, making them competitive in the medical device or imaging industries. Graduates will be equipped to provide in-house regulatory expertise to device companies, or join government regulatory and compliance institutions.

Admissions Requirements

To apply, please review the application requirements and create an online application account:

Application Requirements

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