6th Qserve MedTech Conference - In-Vitro-Diagnostics
11 November 2026, Amsterdam. Two sessions on IVDR readiness and companion diagnostics, with lessons from real CDx submissions.
The IVD track brings together Qserve's IVD experts, Notified Bodies, and industry speakers for two sessions in a single day, covering IVDR readiness and companion diagnostics.
The first session is an honest look at where organizations actually stand on IVDR: how to assess your own readiness, spot the gaps, and prioritize what to fix first. The second turns to companion diagnostics, walking through the lessons learned from real CDx submissions and how to avoid the same pitfalls.
Amsterdam, 11 November 2026.
Who this track is for
This track is built for anyone working on IVD compliance or preparing a companion diagnostic submission.
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Regulatory affairs professionals assessing where their IVDR compliance program stands and what to prioritize next
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QA and compliance leads responsible for closing IVDR readiness gaps
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Companion diagnostics teams preparing a CDx submission, or reviewing lessons from past ones
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Diagnostics manufacturers weighing how ready they are for IVDR against where they thought they'd be
Sessions: IVD
Two 90-minute sessions on 11 November 2026
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Session 1 Day 1 · 11 Nov · 11:00–12:30
IVDR Readiness: How Prepared Are You Really?
IVDR compliance remains a major challenge. This session helps you assess your readiness and identify gaps.
You will learn how to prioritize actions and ensure compliance in a complex regulatory environment.
Speakers
- Kristiane Schmidt, PhD, Principal Consultant, IVD Lead Qserve
- Molly Rogers, Head of IVDRDNV
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Session 2 Day 1 · 11 Nov · 14:00–15:30
Companion Diagnostics (CDx): Submission Lessons Learned
Companion diagnostics present unique regulatory challenges. This session explores lessons learned from CDx submissions and how to navigate them successfully.
Speakers
- Daphne Smit-van den Hof, Sr. Clinical Project Manager Qserve
- Maurice Steenhuis, Medical Technology Assessor CCMO
- Julie Mutert, Associate Director Regulatory Affairs CellCarta
Featuring Trusted Speakers From
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Choose Your Conference Experience
Pre-Conference Workshop Ticket
Join our hands-on pre-conference workshops on 10 November 2026 and gain practical insights through focused sessions designed to prepare you for the latest MedTech regulatory challenges.
€899,-
Conference Ticket
Attend the two-day conference on 11 and 12 November 2026 to access expert-led sessions, industry insights, and valuable networking with MedTech professionals.
€1299,-
Full Conference Ticket
Get the complete experience with access to both the pre-conference workshops on 10 November and the full two-day conference on 11 and 12 November 2026.
€1599,-
We offer group tickets and special offers, contact training@qservegroup.com for more information.
We offer group tickets and special offers, contact training@qservegroup.com for more information.
General and Startups
Through 5 sessions, gain practical insights into regulatory strategy, funding and scaling challenges tailored to emerging MedTech companies and innovators.
Digital Health
Across 5 sessions, explore how evolving regulations, AI, and software-driven innovation are reshaping compliance and market access for digital health technologies.
Global Registrations
Over 3 sessions, learn how to efficiently navigate international regulatory pathways and accelerate market access across key global regions.
Clinical
In 5 sessions, discover best practices for clinical strategy, PMCF data collection, PMCF surveys with real-world data and more.
Demonstrations
Across 3 live demonstrations, experience Qserve Learn, Qserve InSight and AI Clinical in action, showcasing solutions to streamline training, regulatory intelligence, and clinical processes.
Qserve Speakers In-Vitro-Diagnostics Track
Kristiane Schmidt, PhD
Principal Consultant
IVD Lead
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Daphne Smit-van den Hof
Sr. Clinical Project Manager