Design Control and Product Development

General

Prefix

MTQ

Course Number

628

Course Level

Graduate

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

Repeatable

No

Goals and Diversity

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: