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QMSQMS
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
        • T-TF-025-005 Summative evaluation observation form
        • T-TF-025-006 Summative evaluation questionnaire
          • Summative evaluation questionnaire
          • QR Codes
          • English Self-Reported Usability Testing Questionnaire
          • Cuestionario de Pruebas de Usabilidad Auto-reportado en Español
        • 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
  • T-TF-025-006 Summative evaluation questionnaire
  • English Self-Reported Usability Testing Questionnaire

English Self-Reported Usability Testing Questionnaire

Please fill in the following personal information:

Full name:

National ID or passport:

Signature:


Date:

Please answer the following questions based on your experience using the device today. Write your answers in the space provided. The evaluator will review your responses and assess your understanding.

What information is produced by the device report?​

Your Answer:


For Evaluator Use
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

Observations:

What is the probability of malignancy for the lesion you analyzed today?​

Your Answer:


For Evaluator Use
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

Observations:

What are the conditions that the device have detected?​

Your Answer:


For Evaluator Use
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

Observations:

Can this report output of the device act as a diagnosis?​

Your Answer:


For Evaluator Use
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

Observations:

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Cuestionario de Pruebas de Usabilidad Auto-reportado en Español
  • What information is produced by the device report?
  • What is the probability of malignancy for the lesion you analyzed today?
  • What are the conditions that the device have detected?
  • Can this report output of the device act as a diagnosis?
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.)