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MTQ 600. Special Problems

Credits: 1-3 View Details
Description: Independent study is available for advanced students wishing to work out a special problem in the major area of concentration. May be repeated to a maximum of three credits.
Semester Offered:
  • Fall
  • Spring
  • Summer


MTQ 620. Medical Device Quality and Regulatory Fundamentals

Credits: 3 View Details
Description: Medical device and quality regulatory requirements for both FDA and international regulations and standards.
Semester Offered: DEMAND


MTQ 622. Quality Engineering

Credits: 3 View Details
Description: Tools and applications for the design and manufacturing of quality medical devices, application of predictive statistics for sampling, statistical process control, and how to address multiple variables through design of experiments.
Semester Offered: DEMAND


MTQ 624. Risk Management

Credits: 3 View Details
Description: Risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards.
Semester Offered: DEMAND


MTQ 626. Medical Technology Quality Systems

Credits: 3 View Details
Description: Application, management responsibilities, and planning concepts of Quality management systems. US and international standard requirements, and current document control processes in the development, manufacture and distribution of medical devices.
Semester Offered: DEMAND


MTQ 628. Design Control and Product Development

Credits: 4 View Details
Description: FDA and ISO design control requirements for medtech product development, translation of user needs into product design, risk management in the design process, and how design reviews and a phased approach assure designs are safe, robust, and effective.
Prerequisites: MTQ 626
Semester Offered: DEMAND


MTQ 630. Design Verification, Validation, and Clinical Evaluation

Credits: 3 View Details
Description: Design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements. Risk management, statistical sampling, and technical reporting.
Semester Offered: DEMAND


MTQ 632. Manufacturing Process Development and Validation

Credits: 3 View Details
Description: Quality tools to validate that a manufacturing process is well characterized, tested, capable, and controlled to demonstrate compliance and control risks and costs. Using designed experiments. Determining sample size and protocal, report writing, and validation.
Semester Offered: DEMAND


MTQ 634. Corrective Action and Preventative Action (CAPA)

Credits: 3 View Details
Description: Methodologies to prevent product failures, anticipate potential problems, and correct them. Continuous quality improvement.
Semester Offered: DEMAND


MTQ 636. Process Control and Monitoring

Credits: 3 View Details
Description: Maintaining process capability and output quality through statistically-based process plans.
Semester Offered: DEMAND


MTQ 638. Supplier Development and Management

Credits: 3 View Details
Description: Building productive relationships with suppliers. Auditing and rating suppliers. Create specifications quality agreements and corrective actions.
Semester Offered: DEMAND


MTQ 644. Medical Technology Quality Internship

Credits: 1-6 View Details
Description: Professional experience in the medical device industry. May be repeated up to a total of 6 credits.
Prerequisites: MTQ 620, MTQ 622, MTQ 624, MTQ 626, MTQ 628
Semester Offered:
  • Fall
  • Spring
  • Summer


MTQ 698. Culminating Experience

Credits: 1-2 View Details
Description: Individual research project with approval of instructor, or a research paper and comprehensive examination. A total of 2 credits are required. Project may be completed over 1 or 2 semesters.
Semester Offered:
  • Fall
  • Spring
  • Summer






The contents in this catalog and other university publications, policies, fees, bulletins or announcements are subject to change without notice and do not constitute an irrevocable contract between any student and St. Cloud State University.