The client is a UK based leading software development company recently developed 2 artificial intelligence algorithms for novel clinical use in ophthalmology and AKI (Acute Kidney Injury) therapeutic areas. The client approached Freyr to help them register this technology as a medical device in USA and EU. As the product was new and unique novel and identification of predicate device was a challenge for such technology.
To know more on Freyr’s end-to-end Regulatory strategy and support that enabled the client for successful classification & registration of medical device. Read the entire project details here.