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 […]
Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745
Author: Suzanne Broussard, PhD | February 25, 2022 The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights […]
