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.
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: 12-24 months or 3 semesters
- 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.
Get further insights into the career options and outcomes for students and alumni of the Regulatory Biomedical Engineering program.
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