Design Controls for Medical Devices and IVDs


2 hours and 30 minutes

Course Overview

This self-paced training course provides a basic understanding of design controls for medical devices and IVDs. It covers how to comply with the U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and the EU Medical Device Regulation. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official.

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