6th Qserve MedTech Conference - General and Startups

Sessions: General and Start-Ups

Five 90-minute sessions across 11 and 12 November 2026

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

   QMS that Works: Building Systems that Truly Add Value

   A Quality Management System should enable, not hinder, your organization. This session focuses on building and maintaining a QMS that drives efficiency, compliance, and continuous improvement.

   You will learn how to move beyond “check-the-box” compliance and create a system that supports your teams and business goals.

   Speakers

   • François Naye, PhD, Senior Consultant, Quality and Regulatory Expert Qserve
     Gunnar Ulrich, Key Account/Sales ManagerDNV
   • Frédéric Daval, Quality Manager Kinetec

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

   Engaging with Regulators: How to Maximize Value from Interactions — MDR vs FDA

   Effective communication with regulatory authorities can significantly impact your success. This session provides practical guidance on how to prepare for and manage interactions with regulators and notified bodies.

   You will learn how to ask the right questions, present your case clearly, and build constructive relationships.

   Speakers

   • Gert Bos, PhD, Chief Scientific Officer and Partner Qserve
   • Lorry Weaver, Principal ConsultantQserve
   • Malte Knowles Schmidt, Global Portfolio Manager SaMD, AI and Cybersecurity TÜV SÜD
   • Diego Faletti, Technical Team Manager BSI
   • Daan Pelgrom, Commercial Manager Europe, Business Area Medical DEKRA

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

   Start-Up Survival Guide: Overcoming Regulatory Challenges — EU vs USA

   Start-ups face unique regulatory hurdles. This session focuses on the most common challenges and practical solutions to overcome them efficiently.

   You will learn how to prioritize resources, build a scalable regulatory strategy, and avoid costly mistakes.

   Speakers

   • Robert Paassen, MSc, Team Manager Regulatory, Start-up Lead Qserve
   • Lorry Weaver, Principal ConsultantQserve
   • Matthias Bellman, Lead Global Business Unit Marketing & Director Global Focus Team Cardiovascular - Medical & Health ServicesTÜV SÜD
   • Daniele Zanotti, CEOStarTric

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

   Clinical Challenges for Start-Ups: From Evidence to Approval

   Generating clinical evidence is one of the biggest hurdles for start-ups. This session explores practical strategies to design and execute clinical activities efficiently.

   You will learn how to align clinical strategy with regulatory requirements while managing limited resources.

   Speakers

   • Robert Paassen, MSc, Team Manager Regulatory, Start-up Lead Qserve
   • Bianca Lutters, PhD, Director of Knowledge Management, Regulatory and Clinical Expert Qserve
   • Richard Holborow, Global Head of Clinical Compliance BSI
   • Daniele Zanotti, CEOStarTric

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

   Submission Success: Lessons Learned from Real Cases

   What makes a submission successful? This session shares real-world lessons learned from regulatory submissions, highlighting common mistakes and best practices.

   You will gain practical insights into how to build a compliant and effective submission file.

   Speakers

   • Bianca Lutters, PhD, Director of Knowledge Management, Regulatory and Clinical Expert Qserve
   • Diego Faletti, Technical Team Manager BSI
   • Bernd Marx, Department Manager Quality Management, Regulatory Affairs and Product Development Vygon Germany
   • Manfred Lubberich, General Manager
     ProMDService