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Make a difference in a growing industry

Graduate Certificate in Medical Device Development

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

Who can benefit from the Medical Device Development certificate?

  • Career changers wanting to enter the medical device field
  • Medical device professionals who want to upgrade their skills to take on new opportunities
  • Individuals who want to expand their industry knowledge and professional network
  • Individuals who want to continue their education, but are not ready to commit to a master’s program*

*Students can apply their graduate certificate credits toward a future master’s degree.

Contact

Mike Winegar

Program Director, M.S. in Regulatory Science
Headshot of Michael Winegar
Email
wine7598@stthomas.edu

Graduate Certificate Requirements

To complete the Graduate Certificate in Medical Device Development, students must successfully complete four required courses and one three-credit elective for a total of 15 graduate credits and maintain a minimum GPA of 2.7.

Take these four courses (12 credits):

  • 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

Choose one technical elective (3 credits):

  • 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: Tier I Countries
  • ETLS 738 International Regulatory Affairs for Medical Devices: Tier II Countries

View the Graduate Programs in Engineering (ETLS) course catalog.

Graduate Programs That Work for You

Our evening class schedules allow both industry professionals and career changers to achieve their educational goals. And each class meets just once per week.

Convenient Schedule

Our programs serve working professionals with busy lives. You choose how quickly you move through the curriculum. And you may start in any of our three starts: fall, spring or summer.

View Our Course Schedule

Attend an Information Session

Student sits in front of computer taking notes.

Attend an Information Session

Attend an online information session to learn program details. Our programs serve working professionals with busy lives. Set your own pace and start fall, spring or summer. Classes are offered in the evenings. We look forward to meeting you.

Join us for an info session

Faculty

Michael Winegar

Michael Winegar

Mr. Winegar is the program director of the M.S. in Regulatory Science program at St. Thomas. Mike’s primary focus is in the areas of medical device regulatory affairs, clinical research, and quality assurance. He has more than thirty years of experience with global medical device and biotechnology companies, with a particular emphasis on neurovascular, cardiovascular, peripheral vascular, and regenerative medicine technologies.

Michael Winegar
Kristina Simmons.

Kristina Simmons

Ms. Simmons is an adjunct faculty at St. Thomas and an Engineering Program Director in the Cardiac Rhythm Disease Management Group at Medtronic. She leads a cross functional team in the product development activities for life saving medical technology. Before joining Medtronic, Ms. Simmons held positions in the areas of Sales, Quality Systems, and Regulatory Affairs at Empi Medical and MinRad / BioVector.

Kristina Simmons
Georgiann Keyport

Georgiann Keyport

Ms. Keyport is an adjunct faculty at St. Thomas and a Senior Advisor and founder of Canopy Regulatory Solutions Inc., a medical product consulting firm, where she had over 30 years of experience in the regulated medical device, biologic, and pharmaceutical industries as a scientist and in leadership roles in Regulatory & Clinical Affairs, Quality Systems, and Product Development.

Georgiann Keyport

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