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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
      • 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
        • Deprecated
          • 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
        • T-TF-025-005 Summative evaluation observation form
        • T-TF-025-006 Summative evaluation questionnaire
        • T-TF-025-007 Summative evaluation report
      • 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
  • Usability and Human Factors Engineering
  • Deprecated

Deprecated

📄️ 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-025-004 Summative evaluation protocol
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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.)