Master of Engineering in Regulatory Biomedical Engineering (rBME)

Program Overview

The Master of Engineering in 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 new program addresses an unmet need for a graduate program 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 industry/government experience study 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.

Download a PDF of the program overview.



Program Outcome

Students who complete the Master of Regulatory Biomedical Engineering program acquire skill sets comparable to those of an engineer with five to seven years of experience, making them competitive in the medical device or imaging industries. Graduates will be equipped to provide in-house regulatory expertise to device companies, or join government regulatory and compliance institutions.

 

Curriculum

The rBME program is 30 credit hours distributed across four areas:

  • Biomedical engineering coursework and practicum (12 credits)
  • Regulatory issues (9 credits)
  • Patent law for engineers (3 credits)
  • Targeted electives from various disciplines (6 credits)

​Students will require 12-24 months or 3 semesters for completion. 

 

Core Curriculum

  • BME  6482 Medical Measurements (3)
  • BME 6483 Medical Instrument Design (3)
  • BME 6994 Biomedical Engineering Regulatory Practicum I (3)
  • BME 6995 Biomedical Engineering Regulatory Practicum II (3)
  • MAE 3171 Patent Law for Engineers (3)
  • RAFF 6201  Introduction to Global Regulatory Affairs (3) 
  • RAFF 6203  Regulatory Strategy in the Development of Devices and Diagnostics (3)
  • RAFF 6205  Regulatory Compliance (3) 


 

Electives

  • BME 4830 Introduction to Medical Imaging Methods (3)
  • BME 6486 Clinical Medicine for Engineers (3)
  • BME 6487 Rehabilitation Medicine Engineering (3)
  • CS 4531 Computer Security (3)
  • CS 4532 Information Policy (3)
  • ECE 6565 Telecommunication Security (3)
  • EMSE 6020 Decision Making with Uncertainty (3)
  • EMSE 6765 Data Analysis for Engineers and Scientists (3)
  • EMSE 6770 Techniques of Risk Analysis and Management (3)
  • MAE 6204 Tissue Engineering (3)
  • MAE 6238 Biomaterials (3)

 

Admissions Requirements

  • Completed online application form
  • Transcripts from all institutions previously attended (including transfer credits)
  • Two (2) letters of recommendation
  • Resume
  • Statement of purpose
  • GRE scores (may be waived for those with significant and relevant work experience)
  • For international students: TOEFL or IELTS scores