The graduate certificate in medical device regulation and evaluation is designed for current and prospective medical device professionals, biomedical engineers, and scientists who wish to learn the regulatory basis of medical device approvals and engineering evaluation. Students gain fluency in regulatory requirements and processes, especially as related to the biomedical engineering of medical devices, including diagnostic, imaging, and therapeutic devices. The program is interdisciplinary between GW's Department of Biomedical Engineering and the School of Medicine Health Sciences regulatory affairs program. Upon completion of the program, graduates will possess a sound, up-to-date technical background in medical device regulation and evaluation. Students may apply the 15 credits earned in this certificate program toward the 30-credit master of engineering in the field of regulatory biomedical engineering degree.
The following requirements must be fulfilled: 15 credits in required courses.
Course List | Code | Title | Credits |
| BME 6045 | Special Topics (Medical Device Evaluation) | |
| BME 6481 | Regulatory Law for Medical Devices | |
| RAFF 6201 | Introduction to Global Regulatory Affairs | |
| RAFF 6203 | Regulatory Device Diagnostics | |
| RAFF 6205 | Regulatory Affairs Compliance | |
