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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
    • Design and development
      • R-TF-012-006 Lifecycle plan and report
      • R-TF-012-009 Validation and testing of machine learning models
      • Usability engineering file
        • R-TF-012-007 Formative evaluation plan
        • R-TF-012-008 Formative evaluation report
        • R-012-014 Summative evaluation plan
        • R-TF-012-015 Summative evaluation report
        • R-TF-012-016 Software usability test guide
    • 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
  • Design and development
  • Usability engineering file

Usability engineering file

📄️ R-TF-012-007 Formative evaluation plan

Purpose

📄️ R-TF-012-008 Formative evaluation report

Characterization of the medical device

📄️ R-012-014 Summative evaluation plan

Objective

📄️ R-TF-012-015 Summative evaluation report

Objective

📄️ R-TF-012-016 Software usability test guide

Usability testing is a technique utilized in user-centered interaction design to evaluate a product by observing how real users interact with it.

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R-TF-012-009 Validation and testing of machine learning models
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R-TF-012-007 Formative evaluation 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.)