According to AI-act and EU-MDR, Artificial Intelligence components of medical devices need to be incorporated into Risk Management, as part of the Technical Documentation for market access.
Example:
Ophthalmology - OCT - diagnostic tool - Altris AI https://www.altris.ai/
Standards:
https://www.evs.ee/en/contact
https://www.evs.ee/en/iso-iec-42001-2023
https://www.evs.ee/en/evs-en-iso-14971-2019-a11-2021
https://www.evs.ee/en/evs-en-iso-13485-2016-a11-2021
https://www.evs.ee/en/evs-en-62304-2006-a1-2015-consolidated
https://www.evs.ee/en/evs-en-60601-1-2006-a1-a12-a2-2021-consolidated
https://www.evs.ee/en/evs-en-62366-1-2015
https://www.hekmat-consulting.de/