The Master of Science degree in Regulatory Science is a 33-credit program. Students in this program will learn how to interpret and apply a very broad array of current regulatory requirements for medical devices and combination products. They will also acquire skills allowing them to implement future changes in regulations, guidance documents and standards. Students are encouraged to select courses, projects and presentations throughout their program that will best serve their professional interests.
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. Please note: Applicants with a GPA less than 3.0 may be asked to provide a GMAT or GRE score.)
To complete the requirements for the Master of Science with a major in Regulatory Science, students must successfully complete 33 graduate semester credits and maintain a GPA of at least 2.7.
Students must complete 27 core credits (11 required courses) from Engineering and an additional 6 elective credits from either the School of Engineering graduate course curriculum, Graduate Business classes listed below or other graduate UST program subject to Faculty Advisor approval.
Courses listed are three credits each unless otherwise noted.
ETLS = Graduate Engineering Courses
BCOM = Graduate Business Communications Courses
SEIS = Graduate Software Engineering Courses
All courses are required [27 credits]:
ETLS 520 Design and Manufacturing in Medical Device Industry
ETLS 601 Program/Project/Team Management
ETLS 721 Medical Device Regulatory Submission
ETLS 722 FDA Medical Device Quality Systems
ETLS 724 Medical Device Clinical Studies
ETLS 731 Combination Products, Drugs and Biologics
ETLS 737 International Regulatory Affairs for Medical Devices
ETLS 550/ ETLS 650/ ETLS 850 Leveraging Leadership for a Lifetime I, II, and III (3 x 1 credit courses)
(Note: these three 1-credit courses are being phased out and replaced with ETLS 660 Engineering Leadership)
ETLS 880 Directed Study (Independent Research)
Select elective courses [6 credits] from the Regulatory Science curriculum or any other UST graduate course list (provided you have the prerequisites met and your faculty advisor has given approval).
Preferred Regulatory Science electives:
ETLS 541 Clinical Evidence (1 credit)
ETLS 542 FDA Submissions and Presentations (1 credit)
ETLS 543 Pre-Clinical Testing (1 credit)
ETLS 544 Medical Device Reimbursement (1 credit)
ETLS 545 Medical Device Risk Management (1 credit)
ETLS 546 Medical Device Verification and Validation (1 credit)
ETLS 720 Anatomy, Physiology and Medical Devices
ETLS 730 Cardiovascular Anatomy, Physiology, and Medical Devices
Other Popular Regulatory Science electives include:
ETLS 501 Production Operating Systems
ETLS 502 Manufacturing Processes
ETLS 571 Automation in the US and Overseas
ETLS 671 Human Aspects of Technical Management
ETLS 771 Materials Engineering
BCOM 535 Persuasion
BCOM 543 Team Skills and Group Processes
BCOM 551 Presentational Speaking
BCOM 640 Technical Writing
SEIS 605 Technical Communications
While there are no prerequisites for any required core course, it is recommended that students take ETLS 721 early in their Program. Doing so provides helpful background information to better understand lecture topics in other required courses.
As some classes are only offered bi-annually, please meet with your advisor for the Regulatory Science program, Dr. Frank Freedman, early in your program to determine the best class sequence. Also, the one-credit “Leveraging Leadership for a Lifetime” series of three courses are meant to be taken at the beginning, midway and at the end of your program.