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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
      • Software
      • Artificial Intelligence
        • R-TF-028-001 AI Description
        • R-TF-028-001 AI Development Plan
        • R-TF-028-003 Data Collection Instructions - Custom Gathered Data
        • R-TF-028-003 Data Collection Instructions - Archive Data
        • R-TF-028-004 Data Annotation Instructions - Visual Signs
        • R-TF-028-004 Data Annotation Instructions - Binary Indicator Mapping
        • R-TF-028-004 Data Annotation Instructions - ICD-11 Mapping
        • R-TF-028-005 AI Development Report
        • R-TF-028 AI Release Report
        • R-TF-028 AI Design Checks
        • R-TF-028-011 AI Risk Assessment
      • Usability and Human Factors Engineering
      • Clinical
    • Design History File
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Artificial Intelligence

Artificial Intelligence

📄️ R-TF-028-001 AI Description

Purpose

📄️ R-TF-028-001 AI Development Plan

Abbreviations

📄️ R-TF-028-003 Data Collection Instructions - Custom Gathered Data

Purpose and Scope

📄️ R-TF-028-003 Data Collection Instructions - Archive Data

Purpose and Scope

📄️ R-TF-028-004 Data Annotation Instructions - Visual Signs

Context

📄️ R-TF-028-004 Data Annotation Instructions - Binary Indicator Mapping

Context

📄️ R-TF-028-004 Data Annotation Instructions - ICD-11 Mapping

Context

📄️ R-TF-028-005 AI Development Report

Introduction

📄️ R-TF-028 AI Release Report

Package Details

📄️ R-TF-028 AI Design Checks

Purpose

📄️ R-TF-028-011 AI Risk Assessment

Risk Assessment Table

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R-TF-012-006 Lifecycle plan and report
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R-TF-028-001 AI Description
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.)