MTQ630

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Design Verification, Validation, and Clinical Evaluation

Applied Education in MedTech Industry Graduate College of Science and Engineering

Prefix

MTQ

Course Number

630

Course ID

00150999

Course Level

Graduate

Instructional Type

Lecture

Grade Type

A-F Only

College/School

College of Science and Engineering

Description

Design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements. Risk management, statistical sampling, and technical reporting.