A Europe based leading healthcare technology services provider was planning to register one of its products in the U.S. and EU market. The scope of the product was introduction of a mobile medical app that could diagnose the results of an IVD. The challenge was to decode the Regulatory requirements for the approval process of both the countries. Freyr assisted the client with understanding the bottlenecks of the project and overcoming them.
Read the case study to decipher how Freyr adopted the best Regulatory approach to register the mobile app with the Agency.