A South Korea-based medical AI software company was willing to expand their two CAD softwares across multiple countries like, Canada, MENA, ASEAN, LATAM and South Africa. Though the SaMDs were approved by the Korea Ministry of Food and Drug Safety (MFDS), the client had no clear understanding of the country-specific Regulatory requirements for SaMDs. Owing to multiple products, services and countries in scope, the deliverables were multi-dimensional and challenging. Each software required varied priorities and market expansion plans, few documents required translation in some countries and the technical dossiers had to be complied for each target country, as per the Health Authority requirements. Additionally, the SaMD regulations were not clearly defined in majority of the countries in scope.
Given the complexity of the requirements, find out how Freyr navigated through the challenges in a phase-wise manner and assisted the client with end-to-end Regulatory services. Discover with this proven case.