Date: 2 June 2026
Location: No.900 Yishan Road, Shanghai (SGS Shanghai Office)
Time: 13:30 - 17:30 CET
Introduction
Join Qserve and Notified Body SGS for an insighful afternoon session focused on key aspects of performance evaluation under the In Vitro Diagnostic Regulation (IVDR): Face to face with Notified Bodies - A comprehensive overview of IVDR Performance Evaluation.
This in-person event will explore the core requirements and practical considerations for ensuring robust and compliant performance evaluation of in vitro diagnostic devices. Qserve's Mike Szymonik & SGS's Lilian Li will provide insights on regulatory expectations, data requirements and structured approaches and provide a comprehensive overview of analytical performance of IVDs.
This session is designed for professionals involved in regulatory affairs, clinical evaluation, and quality management who are looking to deepen their understanding of IVDR requirements and strengthen their approach to evidence generation for IVD compliance.
Agenda
| 13:00-13:30 | Registration |
| 13.30 - 13:45 | Opening Speech & SGS Introduction |
| 13.45 - 14.00 | Qserve Introduction |
| 14.00 - 14:30 | Mike Szymonik (Qserve) - Performance evaluation under IVDR |
| 14.30 - 15.30 | Lilian (SGS) - Analytical Performance of In Vitro Diagnostic Devices: A Comprehensive Overview |
| 15.30 - 15:45 | Coffee Break |
| 15:45 - 17:15 | Mike Szymonik (Qserve) - Clinical Performance Evaluation of IVDs: data requirements and conduct of clinical performance studies |
| 17.15 - 17:30 | Q&A |
Register now. More details about the event will follow soon.