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MTQ 628. Design Control and Product Development

Credits: 4
Department: Regulatory Affairs
Description: 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.
Prerequisites: MTQ 626
Semester Offered: DEMAND
Grading Method: ABCDF

Student Learning Outcomes

1. Apply ISO and FDA requirements for design control of medical devices
2. Integrate risk management into the design process
3. Manage the integration of user needs, design input, design output, design verification, design validation, and design review in the product development process
4. Demonstrate concepts of design control through completion of a mock product development project.
5. Define methods for Qualification of Test Methods






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