8602 - Medical Technology Quality

General

Program Title
Medical Technology Quality
Degree Designation
MS
Program Level
Graduate
Instruction Mode
On Campus
Program Description
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.
Department(s)
Applied Education in MedTech Industry
College/School
College of Science and Engineering
Status
Active

Requirements

Admissions Requirements

  • The GRE is not required if you have at least three years of work experience following the award of your undergraduate degree.

  • "A baccalaureate degree in science areas, engineering, mathematics, public health, statistics, nursing or other appropriate and relevant areas is recommended as a basis for successful completion of the M.S. MTQ degree. "

  • Three to five years or more of work experience following graduation from an undergraduate degree is highly preferred for admission consideration.

Learning Outcomes

Objective
Knowledge of medical device and quality regulatory requirements for both FDA and international regulations and standards
Objective
Knowledge of how to build productive relationships with suppliers. Auditing and rating suppliers. Create specifications quality agreements and corrective actions
Objective
Knowledge of tools and applications for the design and manufacturing of quality medical devices, including application of predictive statistics for sampling, and how to address multiple variables through design of experiments
Objective
Knowledge of risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards
Objective
Knowledge of the 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.
Objective
Knowledge of 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
Objective
Knowledge of design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements
Objective
Knowledge of 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 protocols, report writing, and validation
Objective
Knowledge of methodologies to prevent product failures, anticipate potential problems, and correct them
Objective
Knowledge of how to maintain process capability and output quality through statistically-based process plans

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