Ellogon AI is a spin off company of the University of Amsterdam, based in Amsterdam that develops Artificial Intelligence software products for the field of health.
Artificial Intelligence is the most promising technology in medicine through which it is expected to help millions of patients around the world.
The experienced and specialized team of partners of Aristi Consulting has undertaken the development, implementation and certification of the quality system of Ellogon.AI for the design, development, production and support of artificial intelligence systems in medicine, based on the requirements of the standards.
- ISO 13485: 2016
- IEC 62304 Medical Device Software
- IEC 82304-1 Health Software
- IEC 62366-1 Usability Engineering for Medical Devices
- ISO 14971 Risk Management for Medical Devices
In addition, it participates in the preparation of the respective technical file based on the IVDR regulation 2017/746, providing know-how.