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] Performance Evaluation Report
This session’s topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these […]