bsi announced that it start­ed pub­lic con­sul­ta­tion for BS AAMI 34971 Guid­ance on the Appli­ca­tion of ISO 14971 to Arti­fi­cial Intel­li­gence and Machine Learning.

The doc­u­ment is intend­ed to pro­vide guid­ance on the appli­ca­tion of a risk man­age­ment process when eval­u­at­ing med­ical tech­nolo­gies that utilise arti­fi­cial intel­li­gence and machine learn­ing. BS AAMI 34971 should be under­stood as a com­ple­men­tary doc­u­ment to ISO 14971. 

On its web­site, bsi states that the pub­lic con­sul­ta­tion for the draft guide­lines is open until 8th August 2021 and they can be accessed here.

The final ver­sion is expect­ed to be ready in late 2021.

Sources: bsi

For more infor­ma­tion on this sub­ject we kind­ly rec­om­mend our arti­cle “Lat­est ver­sion of ISO 14971 on risk man­age­ment and the MDR and IVDR“.