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 course work, students gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.

The following requirements must be fulfilled: 30 credits, including 24 credits in required courses and 6 credits in elective courses. 

Required
BME 6482Medical Measurements
BME 6483Medical Instrumentation Design
BME 6994Biomedical Engineering Regulatory Practicum I
BME 6995Biomedical Engineering Regulatory Practicum II
MAE 3171Patent Law for Engineers
RAFF 6201Introduction to Global Regulatory Affairs
RAFF 6203Regulatory Device Diagnostics
RAFF 6205Regulatory Affairs Compliance
Elective
6 credits from the following:
BME 4820Anatomy and Physiology for Engineers
BME 4830Introduction to Medical Imaging Methods
BME 6486Clinical Medicine for Engineers
BME 6487Rehabilitation Medicine Engineering
CSCI 4531Computer Security
CSCI 4532Information Policy
ECE 6565Telecommunications Security
EMSE 6020Decision Making with Uncertainty
EMSE 6765Data Analysis for Engineers and Scientists
EMSE 6770Techniques of Risk Analysis and Management
MAE 6204Tissue Engineering
MAE 6238Biomaterials