We are delighted to introduce our latest white paper: Post-Market Surveillance and Vigilance.

This comprehensive resource is designed to assist medical device manufacturers in navigating the complexities of regulatory compliance under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The Importance of Post-Market Surveillance and Vigilance

Effective post-market surveillance (PMS) and vigilance are critical to ensuring the safety and performance of medical devices after they enter the market. These processes enable manufacturers to proactively address risks, enhance product safety, and maintain compliance with stringent regulatory requirements.

Our white paper explores key regulatory obligations and practical implementation strategies, including:

  • The foundation of PMS and vigilance in the EU MDR and IVDR.

  • Critical components of an effective PMS system, such as data collection, risk management, and corrective actions.

  • How to leverage post-market clinical follow-up (PMCF) to ensure long-term device safety and efficacy.

What You Will Learn

This white paper provides actionable insights into:

  • Key MDR Articles related to PMS and vigilance, such as Article 83 on PMS Systems and Article 85 on PMS Reports.

  • Best practices for designing and implementing PMS systems, including the use of trend analysis, registries, and feedback mechanisms.

  • Required documentation and reporting protocols to maintain compliance, such as FSCA and PSURs.

Whether you’re a manufacturer, regulatory professional, or quality manager, this white paper is a must-read to ensure your processes align with the latest regulatory standards.

Download the White Paper

Discover how to establish and maintain robust post-market surveillance and vigilance systems. Download your copy of Post-Market Surveillance and Vigilance.

Partner with confinis

At confinis, we specialize in guiding medical device manufacturers through the complexities of PMS and vigilance. Our team of experts provides end-to-end support to help you stay compliant and protect patient safety.

For more information, contact us!