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7-Point Action Plan for MedTech: Navigating Post-Market Surveillance under the EU MDR

With the transition period for adapting to the EU Medical Device Regulation (EU MDR) ending soon, 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: 

 

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