PRISMA-Compliant Literature Reviews: What “PRISMA-Compliant” Actually Means for Your CER or PER
Author: Sarah Chavez, Director of IVD and Scientific Writing Services For medical device and IVD manufacturers, literature reviews are much more than background research. They are an important component of […]
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 […]
