Vigilance & PMS

With you we develop, implement and complete compliant, efficient Post Market Surveillance plans and processes for vigilance including definition, recording, analyses and CAPA on feedback.

This assistance can involve:

  • Patient / Customer  / User Feedback

  • Complaint handling, recording and responses

  • Post Market Clinical Follow Up (PMCF)

  • Adverse Event / Incidents Risk Management

  • Trend Analysis and reporting

  • Medical Device incident reporting to relevant authorities

  • Field Safety Notice (FSN)

  • Field Safety Corrective Action (FSCA)

  • Corrective & Preventative Action (CAPA), issue resolution / remediation.

  • Standard Operating Procedures
  • Regulations & Standards
  • PMS Planning
  • Post Market Clinical Follow Up (PMCF)
  • Corrective & Preventative Action (CAPA)
  • Consumer and Customer Feedback
  • Complaints
  • Adverse Event  / Risk Management
  • Device Returns
  • Trend Analysis:
  • Adverse Trends
  • Field Safety Notice (FSN)
  • Field Safety Corrective Action (FSCA)

Would you like to know more?

We commit to assist and promptly respond to your enquiries; please complete the form and/or contact us on one of the following: