Sverre Sandberg

Filling the gaps in high-priority reference materials for implementing metrological traceability in laboratory medicine

Abstract The global harmonization of measurements in laboratory medicine is facilitated by the development and implementation of reference measurement systems, including suitable certified reference materials (CRMs). There are, however, a relatively small number of CRM producers...

Model 1b analytical performance specifications – report on the Prague 2025 workshop

diagnostic medical devices (IVD MD) meet regulatory and quality standards before market release; for external quality assurance assessments; for quality control, monitoring reagent lot-to-lot variability, and allowing preanalytical variation assessments in labs; and for guiding p...