Post market surveillance is a crucial part of the medical device lifecycle and is emphasized in both EU MDR 2017/745 and IVDR 2017/746.

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).

Contact us for further information or if you want to learn more about how we can support you.

Stockholm Office Färögatan 33, 164 51 Kista, Sweden.
Lund Office Scheelevägen 17, 223 70 Lund, Sweden.

+46 8 621 01 05

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