Medical Device Regulation and Evaluation

Graduate Certificate Program

Program Overview

Certificate Program:

The online graduate certificate program in medical device regulation and evaluation is designed for current and prospective medical device professionals, biomedical engineers, and scientists who want to learn the regulatory basis of medical device approvals and engineering evaluation. Students will 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, current, 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.

Program Requirements

Credit hours: 15 credits

  • Biomedical Engineering course on Medical Device evaluation (3 credits)
  • Biomedical Engineering course on Medical Device Law (3 credits)
  • Regulatory affairs courses (9 credits)

Duration: ‚Äč9 months of remote learning

Admissions Requirements

  • Minimum of 3.0 GPA (on a 4.0 scale) achieved on the final 60 credit hours of undergraduate coursework.
  • Successful submission of online application form, exam scores and other documents as outlined in the admissions requirements.
  • GRE may be waived for those with significant work experience. Please contact [email protected] to inquire.

Professional Outcomes

This certificate in medical device regulation and evaluation represents training in the basics of medical device regulation. By completing the academic requirements you will be able to apply engineering to regulatory solutions needed for medical device development, evaluation, commercialization, law, and policy.  

Get further insights into the career options and outcomes from students and alumni of the Regulatory Biomedical Engineering program. Learn More -