##  [End-to-End Regulatory Services for SaMD Registration with the ANVISA and BRH Support](/case-studies/end-to-end-regulatory-services-for-samd-registration-with-the-anvisa-and-brh-support) 

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





[ANVISA](/case-studies-heath-authority/anvisa)

 

 ![End-to-End Regulatory Services for SaMD Registration with the ANVISA and BRH Support]()

A German-based leading provider of health tech solutions wanted to launch their Software as Medical Device (SaMD) in Brazil. The device had to be registered with Brazil’s Regulatory Agency – ANVISA and the client was unaware of the necessary Regulatory requirements. In addition, the technical files and labeling information were to be provided in Portuguese and owing to the language barrier, communications with the Health Authority was difficult and challenging.

Discover how Freyr provided end-to-end Regulatory support for device registration in Brazil. Download the proven case.



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