Artificial Intelligence

 

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 

 

 

 

 

 

 

 

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