ISO/TS 24971-2 first edition covering application of ISO 14971 to machine learning in medical device
By Jonas A. Bundgaard July 8, 2026
ISO/TS 24971-2 introduces practical guidance for applying ISO 14971 to AI and machine learning medical devices. Read our practical overview.
By Jonas A. Bundgaard June 20, 2024
What is the difference between a 'TR', 'TS', 'IS' and 'EN? ๐Ÿค”
IEC 62304 revision
By Jonas A. Bundgaard June 20, 2024
Snapshot of most important developments and revision in ISO/IEC within standardisation for Medical Devices