6th Qserve MedTech Conference - Clinical

Sessions: Clinical

Five 90-minute sessions across 11 and 12 November 2026

1. Session 1 Day 1 · 11 Nov · 11:00–12:30

   High-Risk Clinical Investigations: Lessons from Clinical Trials

   High-risk clinical investigations require careful planning and execution. This session shares real-world experience from a novel heart valve case.

   Speakers

   • Wouter Mattheussens, MSc, Clinical Project Manager Qserve
   • Sara Haimanot, Internal Clinician, Notified Body DEKRA
   • Wiebe Postma, Associate Director Global Clinical AffairsBVI Medical

1. Session 2 Day 1 · 11 Nov · 14:00–15:30

   Clinical Evaluation for Software & AI Devices

   Clinical evaluation for software and AI devices requires a tailored approach. This session provides practical guidance on demonstrating clinical performance and safety.

   Speakers

   • Jorn van Binsbergen, MSc, Senior Consultant, Regulatory and Clinical Expert Qserve
   • Dr. Yun-Hsuan Chang, Internal Clinician Scarlet
   • Floor van Leeuwen, RA/QA Manager IQMessenger

2. Session 3 Day 2 · 12 Nov · 10:00–11:30

   Turning Real-World Data into a Regulatory Asset

   Collecting PMCF data is often seen as resource-intensive and complex, yet much of the required data already exists within your organization or can be captured with minimal additional effort.

   This session focuses on how to design efficient, low-burden PMCF strategies that deliver meaningful clinical evidence while staying compliant with MDR and IVDR requirements. You will learn how to leverage existing data sources such as PMS data, complaints, literature, and registries, and how to integrate PMCF activities into routine processes.

   Through practical examples, we will show how to reduce effort, avoid over-engineered studies, and still meet regulatory expectations for clinical evidence and CER updates.

   Speakers

   • Bianca Lutters, PhD, Director of Knowledge Management, Regulatory and Clinical Expert Qserve
   • Stéphanie Flipo, Director Clinical Strategy, MedTech, EU Veeva

3. Session 4 Day 2 · 12 Nov · 11:30–13:00

   PMCF Surveys — Minimum Effort, Maximum Output!

   PMCF surveys are a key tool for real-world data collection. This session focuses on designing and implementing effective surveys.

   Speakers

   • Wouter Mattheussens, MSc, Clinical Project Manager Qserve
   • Richard Holborow, Global Head of Clinical Compliance BSI
   • Martin Stofanko, Quality & Regulatory Director Adaptix

4. Session 5 Day 2 · 12 Nov · 14:00–15:30

   Closing the Loop: PMS, PMCF, Risk Management & Clinical Evaluation

   Post-market surveillance, PMCF, risk management, and clinical evaluation are deeply interconnected. This session explains how to align these processes effectively.

   Speakers

   • Jorn van Binsbergen, MSc, Senior Consultant, Regulatory and Clinical Expert Qserve
   • Inge Willems, Project Manager DEKRA
   • Daphne Zwartjes, MSc, Vice President Regulatory Affairs & Quality Assurance TSC-Life