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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
    • Legit.Health Plus STED
    • Legit.Health Plus description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File (DHF)
    • 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-007-003 Periodic Safety Update Report (PSUR) 2023_001
      • R-TF-007-004 Post-Market Surveillance (PMS) Report
      • R-TF-007-005 Post-Market Clinical Follow-up (PMCF) evaluation report_2023_001
      • deprecated
    • Quality control
    • Risk Management
  • Licenses and accreditations
  • External documentation
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  • TF_Legit.Health_Plus
  • 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-007-003 Periodic Safety Update Report (PSUR) 2023_001

General information

📄️ R-TF-007-004 Post-Market Surveillance (PMS) Report

This report summarises the post-market surveillance activities conducted according to the R-TF-007-001 Post-market surveillance (PMS) plan for the legacy device called Legit.Health (hereinafter, the Legacy Device) which is a class I medical device according to MDD 93/42/EEC. The legacy device is equivalent to the device called Legit.Health Plus that is classified as class II medical device according to MDR 2017/745.

📄️ R-TF-007-005 Post-Market Clinical Follow-up (PMCF) evaluation report_2023_001

Details

🗃️ deprecated

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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.)