##  [Successful Classification & Registration of Medical Device in the US and EU](/case-studies/successful-classification-registration-of-medical-device-in-the-us-and-eu) 

- [Medical Devices](/case-studies-main-categories/medical-devices)
- [Market Access](/case-studies-main-categories/market-access)





[US FDA](/case-studies-heath-authority/us-fda)

 

 ![Successful Classification & Registration of Medical Device in the US and EU]()

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.



Fill the form below to download the Case Study

 You must have JavaScript enabled to use this form.

  

  

  

 How did you hear about us?Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther 

  

 

 

     I have read the [privacy policy](https://www.freyrsolutions.com/privacy-policy) 



 

 Submitted Page URL  

 Website URL  

 Content Type  

 Form Name