CE-Post Market Surveillance

Stay compliant in any market. Unload the burden of post-market surveillance activities to the experts!

We offer full-service Post-Market Surveillance (PMS) planning and execution for all markets, for every device classification and all clinical specialties. Regulations related to PMS vary throughout countries and regions. With laws changing regularly, staying compliant can be tricky. It’s important to have a deep understanding of the marketing and reporting requirements in each jurisdiction for your device classification. Our team of professionals has extensive experience in PMS compliance in the US, EU, Canada, and more. We will work with you to develop a risk-based approach to PMS processes to ensure that your product complies with the necessary regulations in every market.

With our in-depth product knowledge covering a wide range of functional and technical disciplines, we provide comprehensive services related to post-market risk management activities. We can help:

• Integrate risk management into your PMS processes,
• Establish PMS processes,
• Post-market clinical follow-up (PMCF) plans and reports,
• PMCF surveys and reports,
• Periodic Safety Update Reports (PSURs),
• Investigate adverse events, and more.