ISO 15194:2026 and Its Impact on the IVD CDMO Industry
The publication of ISO 15194:2026 marks an important update to the international framework governing certified reference materials used at higher levels of metrological traceability in laboratory medicine. For the IVD CDMO industry, the significance of the new standard goes beyond reference material producers themselves. Companies involved in assay development, calibrator development, control material manufacturing, analytical validation, reagent manufacturing, technology transfer, and regulator...
