Medical Technology Quality
- Admission requirements
- Program details
- Course descriptions
Department: Health Sciences
Mr. Brian Rembish
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.
- 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.
Length of Program - Measured by Semesters
- Part-time student: 6 semesters over 2 years
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.