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.
The Regulatory Biomedical Engineering?program is offered at George Washington University.