Post-Market Surveillance & Vigilance

A proactive PMS system is mandatory under MDR. We help you set up systems to monitor device performance and manage vigilance reporting.

PMS & Vigilance support:

  • PMS Plan and Report / PSUR
  • Vigilance reporting (MIR form)
  • Trend analysis and signal detection
  • Field Safety Corrective Actions (FSCA)
  • PMS procedure development
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Post-Market Surveillance and Vigilance

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