Webinar 1: Understanding Regulatory Requirements and Standards Deadlines
Get a clear overview of the regulatory requirements under the In Vitro Diagnostic Regulation (IVDR), including key deadlines for implementing a compliant QMS, lodging formal applications, and signing agreements with a Notified Body.
Hear from our leading subject matter experts who provide a clear roadmap to navigate these requirements and ensure your devices remain compliant.
Originally aired on 22 May 2025. Now available on-demand.
Webinar 2: Demonstrating State of the Art for In Vitro Diagnostic Medical Devices
Learn how to define and apply state of the art (SOTA) in line with current industry guidance. This session covers how to address SOTA in the Performance Evaluation Plan, Performance Evaluation Reports, and Summary of Safety and Performance.
Originally aired on 10 June 2025. Now available on-demand.
Webinar 3: Best Practices for Performance Evaluation Reports/PMPF/PMS
This session covers key methodologies and best practices for developing Performance Evaluation Reports, PMPF, and PMS. Learn how to generate high-quality clinical evidence and avoid common pitfalls when demonstrating the performance and utility of your IVD devices.
Originally aired on 08 July 2025. Now available on-demand.
Who should attend?
This webinar series is relevant for IVD manufacturers, distributors, importers, and consultants working in the IVD space.
