Overview

This webinar will focus on the critical aspects of Clinical Evaluation Reports/PMCF/PMS. Learn about the methodologies and best practices for demonstrating the clinical utility and effectiveness of your IVD devices. Our experts will share best practices and common issues to help you design robust validation studies and generate high-quality evidence for your state-of-the-art IVD.

Key takeaways and learning objectives

• Performance Evaluation - Brief Overview
• Post Market Surveillance
• Performance Evaluation Report – Best Practice
• PMPF – to be or not to be?

Presenter information

Seán O'Callaghan - Technical Specialist and Scheme Manager