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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Artificial Intelligence
    • Clinical
    • Cybersecurity
    • Design and development
    • Design History File
    • IFU and label
    • Post-Market Surveillance
      • R-TF-007-001 Post-Market Surveillance (PMS) Plan
      • R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan
      • R-TF-007-005 Post-Market Clinical Follow-up (PMCF) report
      • deprecated
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Post-Market Surveillance

Post-Market Surveillance

📄️ R-TF-007-001 Post-Market Surveillance (PMS) Plan

Purpose

📄️ R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan

Objective

📄️ R-TF-007-005 Post-Market Clinical Follow-up (PMCF) report

Details

🗃️ deprecated

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R-TF-001-006 IFU and label validation 2023_001
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R-TF-007-001 Post-Market Surveillance (PMS) Plan
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)