Master of Engineering in the Field of Regulatory Biomedical Engineering
The master of engineering in the field of regulatory biomedical engineering (rBME) is an interdisciplinary program offered through the Department of Biomedical Engineering in partnership with the School of Medicine and Health Sciences. The program is designed to train engineers in the specific set of skills of regulatory science, biomedical innovation, and entrepreneurship. Students with training in engineering or physics, and/or relevant experience in government and industry, learn 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 to coursework, students gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.
Visit the program website for additional information.
The following requirements must be fulfilled: 30 credits, including 24 credits in required courses and 6 credits in elective courses.
|BME 6481||Regulatory Law for Medical Devices|
|BME 6482||Medical Measurements|
|BME 6483||Medical Instrumentation Design|
|BME 6994||Biomedical Engineering Regulatory Practicum I|
|BME 6995||Biomedical Engineering Regulatory Practicum II|
|RAFF 6201||Introduction to Global Regulatory Affairs|
|RAFF 6203||Regulatory Device Diagnostics|
|RAFF 6205||Regulatory Affairs Compliance|
|6 credits from the following:|
|BME 6486||Clinical Medicine for Engineers|
|BME 6820||Anatomy and Physiology for Engineers|
|BME 6830||Introduction to Medical Imaging Methods|
|BME 6487||Rehabilitation Medicine Engineering|
|CSCI 4531||Computer Security|
|CSCI 4532||Information Policy|
|ECE 6565||Telecommunications Security|
|EMSE 6020||Decision Making with Uncertainty|
|EMSE 6765||Data Analysis for Engineers and Scientists|
|EMSE 6770||Techniques of Risk Analysis and Management|
|MAE 6204||Tissue Engineering|