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A two-part webinar series

PMS & PMCF Compliance for Medical Devices Under EU MDR

Watch our two on-demand webinars and discover how to turn PMS & PMCF compliance into clinical and strategic advantage — with exclusive insights from a notified body.

Register here

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Clinical & Regulatory Affairs

Unlock the strategic value of PMS and PMCF under EU MDR

Far beyond a compliance checkbox, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) are essential drivers of product safety, clinical validation, and long-term market success. Through real-world insights and practical strategies, QbD Group will show you how to turn regulatory obligations into strategic advantages.

Register to get access to two webinars designed to equip you with the knowledge and tools to elevate your PMS and PMCF systems.

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Detailed Session Information

Navigating Post-Market Compliance Under MDR

SESSION 1

Achieving CE marking is just the beginning. This webinar will clarify how Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements shift once your medical device is on the market.

You'll get practical guidance on staying compliant under EU MDR—especially for legacy devices already in use.

What you'll learn:

• Understand how PMS obligations evolve after CE marking
• Learn how to integrate PMCF activities into your PMS strategy
• Discover what notified bodies typically encounter in audits
• Get practical insights on PSURs, PMS reports, and CER updates
• Avoid common pitfalls through real-world examples

Watch on demand

PMCF in Practice – Strategies, Tools & Expert Insights

SESSION 2

This session dives into the practical side of PMCF. Our team will share how we approach PMCF activities such as clinical investigations, literature reviews, usability studies, and surveys.

A notified body expert will join to provide real audit insights and share what they expect to see in your technical documentation.

What you'll learn:

• Learn how to choose the right PMCF activities for your device
• Understand what notified bodies expect (and flag) in PMCF files
• Hear about common nonconformities and how to avoid them
• Explore workarounds if you lack data or access to patients
• Take away actionable templates and field-tested strategies

Watch on demand

Speaker Panel

Learn from industry-leading regulatory professionals and our exclusive notified body guest speaker.

Petra De Geest

Medical Affairs Manager (webinar 1)

Caroline Aernouts

Senior Consultant RA Medical Devices (webinar 1)

Sarah Andries

Clinical Regulatory Manager (webinar 2)

Kristof Vanschoonbeek

Clinical Team Manager (webinar 2)

Ana Ortiz

Medical Writer (webinar 2)

Matthias Bellmann

TÜV SÜD - MDR Notified Body (webinar 2)

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Our support

Do you like to know how we can help you with tailored, efficient, and MDR-compliant strategies that turn regulatory obligations into clinical and commercial value? Discover our end-to-end PMCF support, from strategy to execution.

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