How to Establish the Competitive Landscape Within the Scientific Validity Report
In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish […]
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” […]
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, […]
