Design Control and Product Development
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General
Prefix
MTQ
Course Number
628
Course ID
00150990
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
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
Credits
Min
4
Max
4
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Apply ISO and FDA requirements for design control of medical devices
Outcome
Integrate risk management into the design process
Outcome
Manage the integration of user needs, design input, design output, design verification, design validation, and design review in the product development process
Outcome
Demonstrate concepts of design control through completion of a mock product development project.
Outcome
Define methods for Qualification of Test Methods
Dependencies
Courses
MTQ628
is a
prerequisite
for:
Programs
MTQ628
is a
completion requirement
for: