RAS623

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Regulatory Routes to Market: 510(k)s

Applied Education in MedTech Industry Graduate College of Science and Engineering

Prefix

RAS

Course Number

623

Course ID

00137409-2022-08-22

Course Level

Graduate

College/School

College of Science and Engineering

Description

U.S. route to market for medical devices, the Premarket Notification of 510(k), and regulation and requirements. Best practices associated with the preparation and clearance of Premarket Notifications. Developing regulatory strategies for markets.