IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
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 […]
It’s All Interconnected: Hidden Traps That Can Derail Your PER
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 Critical Concepts
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, […]
