Graduate Certificate in Medical Device Development

The Graduate Certificate in Medical Device Development is  designed to meet the needs of the rapidly growing medical device industry. This program supports the unique needs of people currently working in or just beginning a career in this industry. As with any rapidly growing industry, applied education that can be put to use immediately is extremely important. The Medical Device Development Certificate offers applied education in the common areas of medical device development and manufacture. 

Who can benefit from the Medical Device Development Certificate?

  • Professionals taking a new assignment or position
  • Professionals who want to upgrade skills
  • Managers who want to know more about the multidisciplinary teams they manage
  • Team members who want to understand the scope of the projects they are working on
  • Suppliers of materials to the medical device industry 

Students have the option to use coursework from their graduate certificate to continue in a Master of Science degree offered through the School of Engineering at the University of St. Thomas.

In response to COVID-19, the University of St. Thomas has made prudent decisions to act on the advice of state and medical professionals.  The format for fall 2021 will be in-person, hybrid or live online, with faculty ready to pivot to have all classes fully online if needed. The classes are still being held during their normal time on weeknights and Saturdays. 

We are happy to help you in every way possible on your journey to apply, register, and start classes. Each of our classes meet once a week or every other Saturday. 

Our staff and faculty are ready to assist you with your questions so e-mail us at gradengineering@stthomas.eduThat is why we are here.   

  • A bachelor's degree from a regionally-accredited educational institution in the U.S. (or international equivalent). 

  • An overall grade-point-average (GPA) of at least 2.7 out of 4.0. (Applicants with a GPA less than 2.7 will be considered for provisional admission with their professional experience factored into the decision.)

To complete the requirements for the Graduate Certificate in Medical Device Development, students must successfully complete four required courses and one three-credit elective (or three one-credit electives) for a total of 15 graduate semester credits and maintain a GPA of at least 2.7.

REQUIRED COURSES (15 total credits) 

Certificate Requirements:

Four required courses (12 credits) + one three-credit elective for a total of 15 credits are required for this certificate.

Required courses (all four courses):

  • ETLS 520 Design Manufacturing in the Medical Device Industry
  • ETLS 721 Medical Device Regulatory Submissions
  • ETLS 722 Medical Device Quality Systems
  • ETLS 724 Medical Device Clinical Studies


Elective courses (choose one three-credit course from the list below):

  • ETLS 720 Anatomy & Physiology for Medical Devices
  • ETLS 731 Combo Products, Drugs and Biologics
  • ETLS 734 Clinical Evidence and Reimbursement
  • ETLS 735 Preclinical Activities
  • ETLS 737 International Regulatory Affairs for Medical Devices

View Graduate Engineering Course Catalog


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