Usability Engineering for Medical Devices using Artificial Intelligence and Machine Learning Technology

This paper explores how to apply the established IEC 62366-1 usability engineering process for safe and effective use of Artificial Intelligence (AI) and machine learning in medical devices. We identify unique factors specific to AI technology that can impact safe use and integrate these considerations into a comprehensive analysis of IEC 62366-1. This analysis results in a step-by-step guide with practical recommendations for identifying, evaluating, and mitigating use-related risks specific to AI devices.