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, […]
[Ask the Expert] Safety and Performance (MDR)
This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What […]
