While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to […]
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge […]
Ask the Expert: Clinical Evaluation Report Template and Critical Concepts This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, […]
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