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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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