Design Controls for Medical Devices and IVDs


2 hours and 30 minutes

Course Overview

This video-based 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 EU MDR. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official.