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MedTech Summit
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)
10 - 14 June 2024
DoubleTree by Hilton Brussels City,
Brussels, Belgium (Hybrid Event)

14 June 2024

How Robust is your PMS strategy?

Get clarity on the PMS requirements with feedback on PSUR, QMS & PMCF methods from Notified Bodies and peer-to-peer experience exchange

Including focused insights on risk management, state-of-the-art, ISO 13485, and more!

Advance your PMS & vigilance systems with practical tips

Notified Body Updates On PMS

  • Post Market Surveillance Plans Under the EU MDR: Notified Body Feedback
  • QMS audits: Hear a Notified Body perspective

Case Studies: Applying The PMS Requirements

  • Gain practical tips on how to statistically justify the evaluation of your PMS plans
  • Implementation insights on enabling risk control throughout the device lifecycle
  • Understand the data flow requirements for a successful Quality Management System (QMS) under ISO 13485
  • Learn how companies are constructing their Periodic Safety Update Reports (PSURs): State of the Art (SotA), benefit vs risk, and contents

Interactive Post Market Panel Discussions

  • Experiences creating and maintaining a robust Post Market Surveillance plan including early adopter feedback, proactive PMS, workload, timelines and lessons learnt
  • Fireside chat: Explore how real world data and evidence can be used successfully to support PMCF
  • Gain an update on the status of Annex XVI from TÜV SÜD and Croma - Pharma