Post-marketing surveillance

Once your product is on the market, Eurofins Medical Device Consulting can handle the post-marketing surveillance to ensure that your product still follows quickly evolving regulations.

We offer to determine a Post-Marketing Surveillance Plan to:

• Define the scope and plan of PMS system,
• the sources and the methods of data collection,
• as well as the methods to analyse data collected.

Our teams also manage the Periodic Safety Update Report (PSUR), which resumes:

• 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. We define the best approach to lead the drafting of the PMCF plan, based on the information provided by the Sponsor. We also study the scope of the PMCF plan and identify relevant documentation to support the PMCF, the parameters to be used to identify relevant data, and the criteria for evaluating these data.

Secondly, the PMCF Report consists of conducting a literature search to identify relevant data concerning both the device and the state of art. It also evaluates the relevant data collected (for example, the data deriving from a survey or a clinical study).