Post-marketing surveillance

When your device receives marketing authorization, Eurofins Medical Device Consulting is your partner for post-marketing surveillance.

We provide a Post-Marketing Surveillance (PMS) Plan to:

• Define the scope and plan of the PMS system
• The sources and methods of data collection
• The methods to analyze collected data

For EU MDR, our team can manage your Periodic Safety Update Report (PSUR), including:

• Post-marketing surveillance activities
• Reactive and proactive activities resulted from post-market surveillance activities
• Conclusions of the analyses of the Post-Market Surveillance data

The Post-Marketing Clinical Follow-up (PMCF) is first set up by a PMCF Plan. Eurofins’ consultants define the best approach for sponsor PMCF plans, leveraging the entire suite of current data.