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MTQ 626. Medical Technology Quality Systems

Credits: 3
Department: Regulatory Affairs
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
Grading Method: ABCDF

Student Learning Outcomes

1. Apply Quality Systems Management
2. Apply specific US and International standards and regulations
3. Determine Management Responsibility in a Quality System
4. Correctly apply Internal Audit processes and requirements
5. Design and apply Records, Documents and Change Control systems
6. Develop content and implement Quality Sytems Manuals
7. Summarize Corrective and Preventive Action (CAPA) Processes

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