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.

PMS

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: