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 […]
[FREE WEBINAR] Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
Click here to watch the recording of this webinar. The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing […]
