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Artificial Intelligence (AI) Medical Devices

Updated: Jul 28, 2022

A useful tool for all medical device software developers considering the use of artificial intelligence (AI) and machine learning (ML) was published on the International Medical Device Regulators Forum's website.

The purpose of this publication is to establish relevant terms and definitions across the Total Product Life Cycle (TPLC) to promote consistency, support global harmonization efforts, and provide a foundation for the development of future guidelines related to ML medical devices. Terms referenced herein have either been previously defined in Global Harmonization Task Force (GHTF) documents or by internationally recognized standards on AI. Some terms and definitions have been generated by or are discussed by the IMDRF Artificial Intelligence Medical Devices (AIMD) Working Group within this document.

IMDRF AIMD WG Final Document N67
Download PDF • 452KB


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