The manufacturers Post Market Surveillance (PMS) system must proactively and systematically gather, record and analyze relevant data on the quality, performance, and safety of the medical device throughout its entire lifetime. As a Manufacturer you are obliged to collect and assess relevant information not only about your own device but also related devices from competitors. A key piece of the PMS is also the Post-Market Clinical Follow-up (PMCF) for MDs and the Post-Market Performance Follow-up (PMPF) for IVDs, where manufacturers must systematically record and evaluate clinical data regarding the safety and performance of their device.

We can support you with:

• PMS procedures.
• PMCF/PMPFP plans and reports.
• Collecting data/Literature review.
• Surveillance and assessment of upcoming changes in relevant standards and regulations.
• Provide training (customized or in open class).
• Complaint and Vigilance handling (including FSCA/FSN).