Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the […]
The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success
Author: Criterion Edge Writers Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is […]
IVD Deep Dive Series Part 1
Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define safety and performance objectives? What are the biggest pitfalls or “Achille’s heels” […]
