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.
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
Our evening class schedules allow both industry professionals and career changers to achieve their educational goals. And each class meets just once per week.
Streamlined Admissions Process
A bachelor's degree from a U.S. regionally accredited institution (or international equivalent) and a minimum GPA of 2.7 is required. The GRE/GMAT is not required.
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.
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.
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.
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.
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.
