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.
The final version is expected to be ready in late 2021.
For more information on this subject we kindly recommend our article “Latest version of ISO 14971 on risk management and the MDR and IVDR“.