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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • 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
      • Cybersecurity
      • Usability and Human Factors Engineering
        • Usability Testing Documentation Guide
        • R-TF-025-001 Usability plan
        • R-TF-025-002 Identification of characteristics for safety and possible use errors
        • R-TF-025-003 User interface evaluation plan
        • R-TF-025-004 Summative evaluation protocol
        • R-TF-025-005 Summative Evaluation Observation Form
        • R-TF-025-006 Summative Evaluation Questionnaire
        • R-TF-025-007 Summative Evaluation Report
        • Deprecated
      • Clinical
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Usability and Human Factors Engineering

Usability and Human Factors Engineering

📄️ Usability Testing Documentation Guide

Overview

📄️ R-TF-025-001 Usability plan

Purpose

📄️ R-TF-025-002 Identification of characteristics for safety and possible use errors

Purpose

📄️ R-TF-025-003 User interface evaluation plan

Scope

📄️ R-TF-025-004 Summative evaluation protocol

List of Tables

📄️ R-TF-025-005 Summative Evaluation Observation Form

Document Information

🗃️ R-TF-025-006 Summative Evaluation Questionnaire

5 items

📄️ R-TF-025-007 Summative Evaluation Report

Document Information

🗃️ Deprecated

5 items

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R-TF-030-005 NIS2-Compliant Incident Response Plan
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Usability Testing Documentation Guide
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.)