Design Controls for Medical Devices and IVDs Overview

About This eLearning

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.

Key Learning Objectives

By the end of this course, you will be able to:

  • Identify design control requirements based on the U.S. FDA Quality System Regulation, ISO 13485:2016 and the EU MDR
  • Recognize how risk management ties into the medical device design control process
  • Recognize FDA’s auditing process and expectations of design controls for medical devices
  • Identify appropriate application of design control requirements

Who Should Attend

This course is important for medical device professionals, especially those who conduct or participate in design phases of any project and/or quality systems activities specific to design control.


By completing/passing this course, you will attain the Medical Device Certificate.