Medical Technology Quality Graduate Program (MTQ)
Offered through the Academic Center for Applied Education in the MedTech Industry
College of Science and Engineering, St. Cloud State University
145 Wick Science Building
Web: http://www.msmtq.com and http://www.stcloudstate.edu/mtq/apply.asp
Graduate Director: Brian Rembish
Department Chair: Dr. David DeGroote
Department Support : Julie Nienaber
Graduate Faculty: http://www.stcloudstate.edu/mtq/faculty.asp
The Master of Science in Medical Technology Quality is designed in close collaboration with the Medtech industry to provide students with the necessary tools and competencies needed to be effective professionals and leaders in medical technology Quality. It will build a solid foundation for students wishing to enter this profession and help to expand and strengthen the knowledge of current quality professionals. The program focuses on the fundamentals of quality for the medtech industry, the medtech regulatory impact, quality systems development and implementation, design and manufacturing process development and validation, and the overall management of quality for the medtech industry. It also provides experience and development competencies in:
- Role of Quality professionals in all phases of product development from concept and design to post market surveillance
- Quality tools and applications in the design and manufacturing of medical technology products.
- FDA and ISO design control requirements for medtech product development and manufacturing.
- Quality Systems management.
Quality professionals play critical roles in the medical technology industry to ensure that medtech companies consistently and effectively meet regulatory standards in quality assurance, traceability, documentation, and continuous improvement, as well as meeting the safety and efficacy needs of the healthcare industry. Quality professionals also play key roles in all aspects of the medical technology product commercialization, from design, development, and manufacturing, to consistently meeting ongoing market needs and expectations. As medical technology and regulations become more complex, it is critical to medtech companies to have Quality professionals with advanced knowledge and understanding to meet the industry needs. Quality professionals with strong knowledge and skills are in high demand by the medtech industry.
Admission Requirements Specific to the Program
- The GRE is not required if you have at least three years of work experience following the award of your undergraduate degree.
- An undergraduate degree in science areas, engineering, math, statistics, nursing or other appropriate and relevant areas is recommended for admission candidacy.
- Three to five years or more of work experience following graduation form an undergraduate degree is highly preferred for admission consideration.
- The director and selected instructors from the Academic Center for Regulatory Affairs and Services will review applications to ensure each candidate’s qualifications for success in the program.
The following Web sites provides admission requirements and a checklist for graduate admissions: http://www.stcloudstate.edu/gradadmissions/
Application Deadlines Specific to the Program
Length of Program - Measured by Semesters
Part-time student: 6 semesters over 2 year
Location and Schedule
The program is offered at the Twin Cities Graduate Center in Maple Grove, Minnesota. For map/location, go online to St. Cloud State University: Twin Cities Graduate Center.
- Two courses are offered each fall and spring semester and one course during summer.
- Generally courses are offered on weekday evenings or Saturday mornings.
- Classrooms, and breakout areas are available for this program.
- Students will have full access to electronic resources via a SCSU HuskyNet account, and instruction will be provided by course management software, currently D2L.
Tuition is $750 per credit for the 2012-13 academic year. Most courses are 3 credits
Master of Science in Medical Technology Quality – 33 Credits
|Course #||Course Title||Semester||Credits|
|Foundational Courses for Medical Technology Quality:|
|MTQ 620.||Medical Device Quality and Regulatory||1||3|
|MTQ 622.||Quality Engineering (EM-560)||2||3|
|MTQ 624.||Risk Management||2||3|
|MTQ 626.||Medical Technology Quality Systems||1||3|
Design and Process Development and Validation:
|MTQ 628.||Design Control and Product Development||3||4|
|MTQ 630.||Design Verification, Validation, and Clinical Studies||4||3|
|MTQ 632.||Manufacturing Process Development and Validation||4||3|
Quality Systems Application and Execution
|MTQ 634.||Corrective Action and Preventative Action (CAPA)||5||3|
|MTQ 636.||Process Control and Monitoring||5||3|
|MTQ 638.||Supplier Development and Management||6||3|
|MTQ 698.||Culminating Experience||4-6||2|
If you have further questions, please contact the College of Science and Engineering at 320.308.2192 or email@example.com