6th Qserve MedTech Conference - Digital Health

Sessions: Digital Health

Five 90-minute sessions across 11 and 12 November 2026

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

   AI in Medical Devices: Practical Guidance for Ensuring Regulatory Compliance and Impact on Submissions

   Artificial intelligence is transforming medical devices, but regulatory compliance remains a key challenge. This session provides a clear overview of how AI-driven devices are regulated under MDR, IVDR, and upcoming guidance. You will explore how AI impacts clinical evaluation, risk management, and submission documentation, including unique considerations for adaptive algorithms and software updates.

   Through practical examples, you will learn how to ensure compliance throughout the lifecycle, anticipate regulatory questions, and document AI components effectively in submissions.

   Speakers

   • Coenraad Davidsdochter, MSc, Team Manager Regulatory & Quality, Software Expert Qserve
   • Malte Knowles Schmidt, Global Portfolio Manager SaMD, AI and Cybersecurity TÜV SÜD
   • Beatrice Federici, Electrical Engineer
     Eindhoven University of Technology

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

   Digital Omnibuses: Navigating through the Transforming Landscape

   Digital technologies are transforming medical devices, diagnostics, and healthcare systems. This session provides a practical overview of regulatory, technical, and clinical considerations for digital health products. You will learn about interoperability, cloud-based solutions, data exchange, and integration into health ecosystems.

   The omnibuses from the AI Act, Digital Health, MDR and IVDR 2.0 and their influence on AI medical devices will be discussed.

   Speakers

   • Coenraad Davidsdochter, MSc, Team Manager Regulatory & Quality, Software Expert Qserve
   • Cécile van der Heijden, Attorney-at-law, Senior Legal Counsel Axon Lawyers

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

   Software, AI & Risk Management: Compliance in Action

   Software is at the heart of modern medical devices, but it introduces specific risks and regulatory requirements. This session explores software lifecycle management, risk management integration, and compliance with IEC 62304 and ISO 14971. You will gain practical guidance on documenting software development, validation, and risk mitigation while maintaining regulatory compliance.

   Through examples and interactive discussion, participants will see how to implement a robust software risk management framework that meets both technical and regulatory standards.

   Speakers

   • Cornelia Luban, PhD, Principal Consultant, Regulatory Affairs Expert Qserve
   • Andrei Ninu, PhD, Head Software Operations Unit DQS
   • Stefan Leitenberger, Risk Management Engineering LeaderPhilips

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

   Cybersecurity in Medical Devices: To a Safer Reality in Healthcare

   Cybersecurity is a core regulatory requirement for modern medical devices. This session provides a practical overview of how to implement cybersecurity across the product lifecycle, aligned with MDR, IVDR, and international guidance.

   You will learn how to identify vulnerabilities, manage threats, and ensure secure design, while maintaining compliance. The session also covers post-market surveillance, incident handling, and expectations from regulators and notified bodies.

   Speakers

   • Mike Szymonik, Senior Consultant, Regulatory Expert IVD and MD Qserve
   • Steven Byrne, PhD, Principal SaMD Expert Scarlet

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

   Navigating Europe’s Digital Health Regulations: EHDS, GDPR & Beyond

   Europe’s digital regulatory landscape is rapidly evolving, with the European Health Data Space (EHDS), GDPR, and other digital health regulations reshaping how medical device and IVD companies manage and use data.

   This session provides a clear, practical overview of how these frameworks interact and what they mean for your organization. You will learn how to ensure compliance with data protection requirements while leveraging opportunities for innovation, including secondary use of health data and real-world evidence generation.

   Speakers

   • Mike Szymonik, Senior Consultant, Regulatory Expert IVD and MD Qserve
   • NB Speaker to be confirmed
     
   • Floor van Leeuwen, RA/QA Manager IQMessenger