Medical Technology Quality Systems
General
Prefix
MTQ
Course Number
626
Course Level
Graduate
Instruction Mode
Lecture
Department/Unit(s)
College/School
College of Science and Engineering
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.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Apply Quality Systems Management
Outcome
Apply specific US and International standards and regulations
Outcome
Determine Management Responsibility in a Quality System
Outcome
Correctly apply Internal Audit processes and requirements
Outcome
Design and apply Records, Documents and Change Control systems
Outcome
Develop content and implement Quality Sytems Manuals
Outcome
Summarize Corrective and Preventive Action (CAPA) Processes