PLAS.5020 — Online and Continuing Education
Id: 004296
Offering: 2
Credits: 3-3
Description
Comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements. Detailed analysis of quality assurance issues and regulatory reforms implemented under the Food and Drug Administration. Provides a step-by-step guide through the Center for Devices and Radiological Health (CRDH) investigational device exemptions, premarket approval, 510 (k) application process, and product development protocol and review processes.
Prerequisites
Students with a CSCE or UGRD career need permission to take Graduate Level Courses.
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