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.
- A bachelor's degree in any discipline from a regionally-accredited educational institution in the U.S. (or international equivalent).
- An overall grade-point-average (GPA) of at least 3.0 out of 4.0. (Applicants with a GPA less than 3.0 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)
Four required courses (12 credits) + one three-credit elective or three one-credit electives (3 credits) 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 1 three-credit course OR 3 one-credit courses listed below):
Three-credit courses (choose one):
- ETLS 720 Anatomy & Physiology for Medical Devices
- ETLS 730 Cardiovascular Anatomy, Physiology and Medical Devices
- ETLS 731 Combo Products, Drugs and Biologics
- ETLS 737 International Regulatory Affairs for Medical Devices
One-credit Medical Device Elective courses (choose three):
- ETLS 541 Clinical Evidence
- ETLS 542 FDA Submissions/Presentations
- ETLS 543 Pre-clinical Testing
- ETLS 544 Medical Device Reimbursement
- ETLS 545 Medical Device Risk Management
- ETLS 546 Verification and Validation