Within the European Union, software used for diagnostic and triage purposes is considered a medical device and needs to comply with the European Medical Device Regulation (2017/745).
All our products comply with the European Medical Device Directive (MDD) and they are transitioning to the new European Medical Device Regulation (2017/745) (MDR).
Under the European Medical Device Regulation, Avicenna.AI has appointed a person Responsible for Regulatory Compliance (PRRC). The role is currently executed by our Regulatory Manager, Stephane Berger.
United States, United Kingdom, Canada, Brazil, Australia
Our products are certified for use in the U.S. Market, United Kingdom, Canada, Brazil, Australia, and more.
Please contact us if you want to know if we are registered in your country and the name of our authorized representative.