Vigilance & Post Market Surveillance

We support you to develop, implement and complete compliant, efficient Post Market Surveillance plans to meet MDD ANX III and embrace the requirements of MEDDEV 2.12/1 rev.8 to ensure effective vigilance, data analysis and reporting.

With you we identify the processes of vigilance and reporting to identify and improve controls to enable effective, continuous monitoring of your products’ safety & performance, trend analysis and effect risk reduction & clinical evaluation.

This can involve appraisal of:

  • Consumer / Customer  / User / Feedback

  • Complaint  / Feedback Handling and Responses

  • Trend Analysis

  • Post Market Clinical Follow Up (PMCF)

  • Risk Assessment / Review / Management

  • Adverse Event / Incidents Management

  • Medical Device Reporting to relevant authorities

  • Field Safety Notice (FSN)

  • Field Safety Corrective Action (FSCA)

  • Corrective & Preventative Action (CAPA)

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