This program will begin in fall 2022
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 the Department of Biomedical Engineering and the regulatory affairs program in the School of Medicine and Health Science. Upon completion of the program, graduates possess a sound, up-to-date technical background in medical device regulation and evaluation.
The certificate’s required curriculum consists of the first two semesters (15 credits) of the master of engineering (MEng) in regulatory biomedical engineering program. With program approval, students enrolled in the MEng program may receive the certificate once they have completed those 15 credits. Alternatively, students may pursue the certificate independent of the master’s.
This program will begin in fall 2022
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 | |
