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MedTech Summit


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19 - 23 June 2023
Sheraton Brussels Airport HotelBrussels, Belgium (Hybrid Event)

19 - 23 June 2023
Sheraton Brussels Airport Hotel,
Brussels, Belgium (Hybrid Event)

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