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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 and development
    • 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
  • Applicable Standards and Regulations
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Usability and Human Factors Engineering
  • T-TF-025-005 Summative evaluation observation form

T-TF-025-005 Summative evaluation observation form

ITP Use Scenario 1: Simulated Use​

TaskOutcomeObservations
Input authorization details
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Input correct URL for login endpoint
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Format the data
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Enter mandatory fields
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Enter data
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Send images to the API
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Send request to the endpoint
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Input correct HTTP method
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Send access token with the request
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Process the request
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Extract the data
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Generate report
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

HCP Use Scenario 1: Simulated Use: No Lesion​

TaskOutcomeObservations
User takes a photo of the patient's hand
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
User logs into the system
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
user uploads photos to the client
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
User generates a report
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)

HCP Use Scenario 2: Simulated Use: Lesion​

TaskOutcomeObservations
User logs into the system
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
User uploads photos to the client
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
User generates a report
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Previous
R-TF-025-004 Summative evaluation protocol
Next
T-TF-025-006 Summative evaluation questionnaire
  • ITP Use Scenario 1: Simulated Use
  • HCP Use Scenario 1: Simulated Use: No Lesion
  • HCP Use Scenario 2: Simulated Use: Lesion
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.)