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  • Welcome to your QMS
  • Quality Manual
  • Procedures
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  • 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
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    • Design History File
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
      • 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
      • T-TF-025-005 Summative evaluation observation form
      • T-TF-025-006 Summative evaluation questionnaire
      • T-TF-025-007 Summative evaluation report
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
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  • Legit.Health Plus Version 1.1.0.0
  • Usability and Human Factors Engineering

Usability and Human Factors Engineering

📄️ 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

📄️ T-TF-025-005 Summative evaluation observation form

ITP Use Scenario 1: Simulated Use

📄️ T-TF-025-006 Summative evaluation questionnaire

HCP Use Scenario 3: Knowledge Assessment

📄️ T-TF-025-007 Summative evaluation report

Scope

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R-TF-025-001 Usability 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.)