7-Point Action Plan for MedTech: Navigating Post-Market Surveillance under the EU MDR
With the EU Medical Device Regulation (EU MDR), many medical device manufacturers feel overwhelmed by the new demands awaiting them, particularly in terms of Post-Market Surveillance (PMS).
This Whitepaper pinpoints 7 key areas manufacturers must address when it comes to their PMS and Post-Market Clinical Follow-up (PMCF) systems, including:
- PMS and PMCF planning
- Appointing a responsible person for PMS
- Setting up a Risk Management System
- Proactive PMS planning versus reactive PMS vigilance
- Gap assessments for existing devices
- Technical documentation
We hope you will enjoy reading this Whitepaper. Feel free to reach out if you have any questions or issues accessing it: