Webinar 1: Understanding Regulatory Requirements and Standards Deadlines
What is the webinar about?
In this session, we will look the regulatory requirements under the In Vitro Diagnostic Regulation (IVDR). Learn about the key transition timeline including deadlines for: having an IVDR compliant QMS, formal applications lodged, and formal written agreements signed with a Notified Body.
Hear our leading subject matter experts who will provide a clear roadmap to navigate these requirements and ensure your devices are compliant.
Webinar 1: 22 May 2025 | 09:00 and 16:00 BST
Webinar 2: Demonstrating State of the Art for In Vitro Diagnostic Medical Devices
What is the webinar about?
This webinar will cover available industry guidance on state of the art for In Vitro Diagnostic Medical Devices. Our subject matter experts will provide definitions of the SOTA. Addressing state of the art in the Performance Evaluation Plan, Performance Evaluation Reports and Summary of Safety and Performance.
Webinar 2: 10 June 2025 | 09:00 and 16:00 BST
Webinar 3: Best Practices for Performance Evaluation Reports/PMPF/PMS
What is the webinar about?
The final session will focus on the critical aspects of Performance Evaluation Reports/PMPF/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.
Webinar 3: 08 July 2025 | 09:00 and 16:00 BST
Who should attend?
This webinar series will be relevant for IVD manufacturers, distributors, importers and the related consulting community.
