A South Korea-based client wanted to market their Class II SaMD products in the EU, US, Australia, Taiwan, Japan, and Korea. The products in scope were used for treating cardiovascular and pulmonary diseases. The client required BRH support and wanted to have their products CE marked as Class IIa in the EU and Australia. They approached Freyr for assistance in end-to-end regulatory services to register their SaMDs in the Brazilian market. However, the client was not familiar with the SaMD prerequisites, and the technical files and labeling information had to be provided in Portuguese.
How did Freyr provide BRH support and end-to-end regulatory services to the client for SaMD registration in the Brazilian market? What were the client benefits? Download the proven case.
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