IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation
IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, […]
How to Establish the State-of-the-Art Within the Scientific Validity Report
How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art […]
[Ask the Expert] Safety & Performance (IVDR)
This session’s topic: Safety and Performance Objectives and Acceptance Criteria for IVDR Do you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are […]
