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IVD Performance Testing
Under the IVDR (In Vitro Diagnostic Regulation), medical diagnostic companies must generate robust analytical and clinical performance data to support CE marking and ongoing post-market surveillance.
Truly Labs provides IVD performance studies and laboratory testing services that produce reliable, well-documented datasets suitable for regulatory submissions and technical files.
Our laboratory supports performance testing across a wide range of diagnostic technologies, including:
Study design, laboratory execution, data analysis, and reporting are performed within our quality management system, ensuring your data meets the evidentiary expectations of IVDR and notified bodies. For diagnostic developers, this means performance data that can move directly into your regulatory technical documentation.
