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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
    • Clinical
      • Evaluation
        • R-TF-015-001 Clinical Evaluation Plan
        • R-TF-015-002 Preclinical and clinical evaluation record_2023_001
        • R-TF-015-003 Clinical Evaluation Report
        • R-TF-015-007 Delaration of interest Alberto Sabater
        • R-TF-015-007 Delaration of interest Alfonso Medela
        • R-TF-015-007 Delaration of interest Constanza Balboni
        • R-TF-015-007 Delaration of interest María Belén Hirigoity
        • R-TF-015-007 Delaration of interest María Diez
        • R-TF-015-007 Delaration of interest Taig Mac Carthy
      • Investigation
      • R-TF-015-008 Clinical development plan
    • Design and development
    • Design History File
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Legit.Health Plus Version 1.1.0.0
  • Clinical
  • Evaluation

Evaluation

📄️ R-TF-015-001 Clinical Evaluation Plan

Purpose

📄️ R-TF-015-002 Preclinical and clinical evaluation record_2023_001

Scope

📄️ R-TF-015-003 Clinical Evaluation Report

Executive summary

📄️ R-TF-015-007 Delaration of interest Alberto Sabater

Declaration of interest

📄️ R-TF-015-007 Delaration of interest Alfonso Medela

Declaration of interest

📄️ R-TF-015-007 Delaration of interest Constanza Balboni

📄️ R-TF-015-007 Delaration of interest María Belén Hirigoity

📄️ R-TF-015-007 Delaration of interest María Diez

Declaration of interest

📄️ R-TF-015-007 Delaration of interest Taig Mac Carthy

Declaration of interest

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R-TF-015-001 Clinical Evaluation Plan
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