The client is an Austria-based, Leading IVD Consulting Firm specializing in creating innovative solutions for software focusing on In Vitro Diagnostics (IVDs) and laboratory devices. The client required Regulatory support in authoring a Scientific Validity Report (SVR) and a detailed analysis of the product’s intended use in the EU region. Freyr assisted the client by streamlining the entire process, conducting a thorough study on support documents, and preparing high-quality drafts and SVR under EU IVDR regulations.

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