15 courses with the subject MTQ, each shown exactly as we captured it from the college's catalog, with every element we hold. Where the wording looks broken, that is our reading of the catalog, not the college's text.
Credit for independent research by a single student arranged and supervised by a faculty member. Not intended for culminating project research such as thesis or starred paper.
[Credits: 3] Medical device and quality regulatory requirements for both FDA and international regulations and standards.
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.
Risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards.
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.
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. Pre- Requisite(s): MTQ626 272
[Credits: 3] Design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements. Risk management, statistical sampling, and technical reporting.
3] 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 protocol, report writing, and validation.
Methodologies to prevent product failures, anticipate potential problems, and correct them. Continuous quality improvement.
Maintaining process capability and output quality through statistically- based process plans.
Building productive relationships with suppliers. Auditing and rating suppliers. Create specifications quality agreements and corrective actions.
Credit for off-campus professional experience with industry partners, non-profit organizations or government agencies. Can serve as a graduate culminating experience in conjunction with a portfolio demonstrating mastery of associated learning outcomes. Pre- Requisite(s): MTQ620, MTQ626, MTQ622, MTQ624, MTQ628
Experimental, temporary or trial course for groups of students all engaged in the same topic. Topic varies from semester to semester or section to section. A specific content offering may be offered under a topics course number up to three times, after which departments must file for a permanent course number. According to Graduate School policy, there is a limit of 9 credits which applies toward a specific program.
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.
A graduate only course that is used for completion of the culminating project of a Master's Degree, including Master's Thesis, Starred Paper and Creative Work. Six credits total are required for graduation for Thesis and Creative Work. Three credits are normally required for Starred Paper.
Source: Saint Cloud State University's catalog, linked per course · table learning_unit · CourseShelf publish 61
