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MTQ 620. Medical Device Quality and Regulatory Fundamentals

Credits: 3
Department: Regulatory Affairs
Description: Medical device and quality regulatory requirements for both FDA and international regulations and standards.
Semester Offered: DEMAND
Grading Method: ABCDF

Student Learning Outcomes

1. Explain the history and purpose of medical technology regulations and standards.
2. Apply the basic quality concepts, tools, and methods used to meet medical device requirements.
3. Analyze and identify the differences, similarities, and interdependencies between regulations and standards applicable to medical devices.
4. Determine the interactions between quality professionals and regulatory bodies.
5. Formulate how compliance provides business value.






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