MS-MTQ Course Narratives

 

MTQ 620: Medical Device Quality and Regulatory Fundamentals: Introduction to basic concepts of quality and medical device regulatory requirements for both FDA and international regulations and standards. 3 Credits

MTQ 622: Quality Engineering: Quality tools and applications in design and manufacturing of medical devices, application of predictive statistics for sampling, statistical process control, and how to address multiple variables through Design of Experiments (DOE). 3 Credits

MTQ 624: Risk Management: Risk management process in the development and use of medical devices to protect patients, operators, and medical professionals from harm. Applicable standards, regulations, methods, and tools for identifying, analyzing, and controlling risks/hazards. 3 Credits

MTQ 626: Medical Technology Quality Systems: Medical technology Quality Management Systems application, management responsibilities, planning concepts, relevant US and international standard requirements, and current document control processes in the development, manufacture and distribution of medical devices. 3 Credits

MTQ 628: Design Control and Product Development: FDA and ISO design control requirements for medtech product development, translation of user needs into product design, risk management in thedesign process, and how design reviews and using a phased approach help assure designs are safe, robust, and effective. 4 Credits

MTQ-630: Design Verification, Validation, and Clinical Studies: Expand on design control requirements by focusing on design verification, design validation, and clinical studies using FDA Quality System Regulation (CFR Part 820) and ISO 13485 requirements and how risk management, statistical sampling, and technical reporting are interwoven. Also learn how end user needs are confirmed via design validation and clinical studies. 3 Credits

MTQ 632: Manufacturing Process Development and Validation: Use of Quality Tools to validate that a manufacturing process is well characterized, tested, capable, and controlled to demonstrate compliance, control risks and costs. Also, developing manufacturing processes, characterization, and optimization using Designed Experiments and determining sample size, protocol, report writing, and ongoing validation requirements to insure product quality. 3 Credits

MTQ 634: Corrective Action and Preventive Action (CAPA): Methodologies medical technology companies use to prevent product failures, anticipate potential problems, and correct them when they occur as well as approaches for continuous Quality improvement. 3 Credits

MTQ 636: Process Control and Monitoring: Fundamentals and application of Process Control and Monitoring Principles towards maintaining process capability and output quality through statistically-based process control and monitoring plans and reaction plans. 3 Credits

MTQ 638: Supplier Development and Management: Select and develop productive relationships with suppliers. Audit and rate suppliers, create specifications that are complete and understandable, and learn how to work with suppliers on corrective actions and create effective quality agreements. 3 Credits

MTQ 698: Culminating Experience: Culminating project, starred paper, and seminar. Student will develop, carry out and report [in written and oral format] on an individual research project related to the content of the program courses. Project requires approval of instructor. If an industry related research project cannot be identified an alternative is a research paper demonstrating integration and understanding of information acquired in at least three courses, a comprehensive written examination covering medical technology quality regulations and standards, and an oral examination demonstrating Quality leadership and critical thinking. Prerequisite: This course can be started earlier but cannot be completed before the final semester of the program. 2 Credits