Published November 22, 2024 | Version V1.0.0
Publication Open

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

  • 1. Benkana Interfaces GmbH & Co. KG
  • 2. ROR icon Johner Institut (Germany)
  • 3. ROR icon Siemens Healthcare (Germany)
  • 4. Philips Healthcare
  • 5. ROR icon Stryker (Germany)

Description

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.

Files

Position Paper - UE for MD using AI_ML Technology_final_draft_2024-10-16.pdf

Additional details

Dates

Submitted
2024-11-22

References

  • IEC 62366-1. (2020). Medical devices - Part 1: Application of usability engineering to medical devices. IEC.
  • ISO/IEC 22989. (2022). Information technology - Artificial intelligence, Artificial intelligence concepts and terminology. ISO/IEC.
  • ISO 14971. (2019). Medical devices - Application of risk management to medical devices. ISO.
  • FDA. (2023, Jun 12). Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. Retrieved Apr 20, 2024, from https://www.fda.gov/medical-devices/software-medical-device- samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices