Master of Engineering in Regulatory Biomedical Engineering

Graduate student conducting experiment on biomedical device in lab

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 program addresses the need to train the next generation of biomedical engineers in the specific skill sets covering regulatory science, biomedical innovation and entrepreneurship.

Students in this program can expect to take courses in 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, students may gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.

Students who complete the program 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. Students will be equipped to provide in-house regulatory expertise to device companies, or join government regulatory and compliance institutions.

Please note: Starting Fall 2022, this program will be changing to a cohort-based program with a fall-only intake. The program will also be changing to 100% virtual. Changes will be made to the coursework requirements but the overall program objectives will remain the same. More information coming soon regarding the specifics of these changes.

Program Requirements

Credit hours: 30 credits total distributed across four topical 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)

Duration: ‚Äč12-24 months or 3 semesters

Program Requirements

Admissions Requirements

  • Minimum of 3.0 GPA (on a 4.0 scale) achieved on the final 60 credit hours of undergraduate coursework.
  • Successful submission of online application form, exam scores and other documents as outlined in the admissions requirements.
  • GRE may be waived for those with significant work experience. Please contact [email protected] to inquire.


Professional Outcomes

Get further insights into the career options and outcomes for students and alumni of the Regulatory Biomedical Engineering program.

Learn more