16 - 20 June 2025
MOA BerlinBerlin, Germany16 - 20 June 2025
MOA Berlin,
Berlin, Germany
MOA Berlin,
Berlin, Germany
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
