Maximizing post-market surveillance with real world data
Medical device recalls are on the rise at the same time as the EU MDR and IVDR are bringing increased post-market surveillance (PMS) requirements.
White Paper
Apr 18, 2020

EU Medical Devices Regulation and In Vitro Diagnostics Regulation are bringing increased post-market surveillance (PMS) requirements for all MedTech firms.

Multiple factors, including the rapid growth in device interoperability, the rise in Software as a Medical Device (SaMD), and increasingly frequent cybersecurity breaches, have been responsible, in part, for the continued rise in recalls, particularly software-related recalls. In this Executive Summary of a recent webinar learn about:

  • Challenges with post-market surveillance
  • Understanding real world evidence
  • The future post-market surveillance safety landscape
  • How to set up a better post-market surveillance approach
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