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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
      • R-TF-028-001 AI/ML Description
      • R-TF-028-001 AI/ML Development Plan
      • R-TF-028-003 Data Collection Instructions - Prospective Data
      • R-TF-028-003 Data Collection Instructions - Retrospective Data
      • R-TF-028-004 Data Annotation Instructions - Visual Signs
      • R-TF-028-004 Data Annotation Instructions - Binary Indicator Mapping
      • R-TF-028-004 AI/ML Development Report
      • R-TF-028 AI/ML Release Report
      • R-TF-028 AI/ML Design Checks
    • Clinical
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    • Design History File
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  • Legit.Health Plus Version 1.1.0.1
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  • Legit.Health Plus Version 1.1.0.0
  • Artificial Intelligence

Artificial Intelligence

📄️ R-TF-028-001 AI/ML Description

Purpose

📄️ R-TF-028-001 AI/ML Development Plan

Abbreviations

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

Context

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

1. Context

📄️ 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 AI/ML Development Report

Introduction

📄️ R-TF-028 AI/ML Release Report

Package Details

📄️ R-TF-028 AI/ML Design Checks

Purpose

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R-TF-008-001 General Safety and Performance Requirements (GSPR)
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R-TF-028-001 AI/ML 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.)