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:

    Design / Develop D&D planning, user requirements, verification, validation & change. Risk Management Planning, hazard identification, risk control, benefit-risk analysis. Audit & Monitor Obtaining data to verify compliance: Improve product(s), plant(s), processes, people & controls. Services Technical Documentation Tech Doc collation to evidence safety & performance & meet national regulations. Change Control Controls & risk management of changes to device(s), processes, systems & Tech Documentation. Clinical Evaluation Clinical Evaluation planning, data review, reporting & updating. Services Data Analysis Practical, proven, efficient KPI's to identify, collate, analyse, act & improve products, processes & people. Doc & Data Control Efficient, reliable, traceable Doc & Data controls. Launch & Distribute Importer / Distributor QMS, agreements, traceability, controls and diligence. Services Management Systems Developing & maintaining effective, compliant QMS; improving product, resources, processes & organisation. NCR & CAPA Identifying, recording, analyzing, preventing & correcting product, process & system issues. Ops Management Effective compliant, efficient controls, (incl. outsourced processes). Services Performance Improvement Implementing improvement in your device life-cycle & compliance. Regs & Standards Identifying & meeting relevant regulations, common specifications & standards. Reg Strategy & Plan Regulatory strategies / plans for device development & clearance to market; FDA, CE, UKCA, UKNI. Services Reg Submission Preparing & collating data to reduce time for complaint submissions to gain clearance for product launch. Verification & Validation Planning, verifying, validating designs, processes, environ controls, equipment, products, plant & test methods. Vigilance & PMS Documenting & implementing PMS / PMCF plans, vigilance system & incident reporting. Services GPB - Design Control GPB - Risk Mangement GPB - Audit Monitoring GPB - Technical Documentation Change Control Clinical Evaluation Data Analysis Doc & Data Control Launch & Distribution Performance Improvement Regulation Standards Regulatory Standards Management Systems NCR & CAPA Operations Control Regulatory Submissions Verification & Validation Vigilance & Post Market