bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning

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“.