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MTQ 630. Design Verification, Validation, and Clinical Evaluation

Credits: 3
Department: Regulatory Affairs
Description: Design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements. Risk management, statistical sampling, and technical reporting.
Semester Offered: DEMAND
Grading Method: ABCDF

Student Learning Outcomes

1. Evaluate & apply FDA Quality Systems Regulations; CFR-Part 820, and ISO-13485 requirements for design control of medical devices, with focus on design verification, design validation & clinical studies
2. Distinguish how risk management fits into the design process
3. Judge the relationship of user needs, design input and design output with respect to design verification, design validation & clinical studies

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