Graduate Certificate in Medical Device Development
Are you looking to advance your career in the medical device field or transition into this booming industry? The Graduate Certificate in Medical Device Development at the University of St. Thomas is designed to provide you with the essential knowledge and hands-on experience needed to thrive in this fast-growing sector.
Choose the Graduate Certificate in Medical Device Development to gain specialized skills and accelerate your career in the medical device industry.
The medical device industry is expanding rapidly, and professionals with specialized knowledge are in high demand. This certificate program is tailored for individuals currently working in or entering the medical device field and focuses on providing practical, immediately applicable education in key areas, including:
Medical device development processes
Regulatory requirements and compliance
Quality control and testing procedures
Design and manufacturing best practices
Risk management and safety protocols
By completing this certificate, students will gain the skills needed to contribute to the design, development, and regulation of medical devices, positioning yourself for new career opportunities and professional advancement.
Who Can Benefit from the Medical Device Development Certificate?
This certificate program is ideal for a wide range of individuals, including:
Career changers looking to enter the medical device industry with relevant, applied knowledge
Medical device professionals seeking to upgrade their skills and prepare for new roles or responsibilities
Industry newcomers wanting to expand their knowledge and build a professional network in the medical device field
Individuals who are interested in continuing their education but are not ready to commit to a full master’s program
Apply your credits toward a STEM-approved Master of Science degree
If you choose to further your education, the credits earned through the Graduate Certificate in Medical Device Development can be applied toward a future Master of Science degree. This seamless pathway allows you to continue advancing your career providing greater flexibility as you expand your expertise.
Graduate Certificate Requirements and Course Overview
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
Enhance Your Career with In-Demand Graduate Certificates
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. Classes are offered in the evenings.
Discover how the Graduate Certificate in Medical Device Development can fit into your busy life. Explore program details, our cutting-edge curriculum, exceptional faculty, and strong industry partnerships. You'll also find valuable information on career development and admissions requirements.
Meet the Faculty: Industry Experts in Medical Device Development
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.
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.
