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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
    • Legit.Health Plus STED
    • Legit.Health Plus description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File (DHF)
      • Version 1.1.0.0
        • Requirements
        • Test plans
        • Test runs
          • TEST_001 The user receives quantifiable data on the intensity of clinical signs
          • TEST_002 The user receives quantifiable data on the count of clinical signs
          • TEST_003 The user receives quantifiable data on the extent of clinical signs
          • TEST_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
          • TEST_007 If something does not work, the API returns meaningful information about the error
          • TEST_008 Notify the user image modality and if the image does not represent a skin structure
          • TEST_009 Notify the user if the quality of the image is insufficient
          • TEST_010 The user specifies the body site of the skin structure
          • TEST_011 We facilitate the integration of the device into the users' system
          • TEST_012 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
          • TEST_013 The data that users send and receive follows the FHIR healthcare interoperability standard
          • TEST-014 The user authentication feature is functioning correctly
          • TEST_015 Ensure all API communications are conducted over HTTPS
          • TEST_016 Ensure API compliance with Base64 image format and FHIR standard
          • TEST_017 Verification of authorized user registration and body zone specification in device API
          • TEST_018 Ensure API stability and cybersecurity of the medical device
        • Review meetings
        • 🥣 SOUPs
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
  • Licenses and accreditations
  • External documentation
  • TF_Legit.Health_Plus
  • Design History File (DHF)
  • Version 1.1.0.0
  • Test runs
  • TEST_011 We facilitate the integration of the device into the users' system

TEST_011 We facilitate the integration of the device into the users' system

Test type​

User acceptance

Linked activities​

  • MDS-461

Result​

  • Passed
  • Failed

Description​

Tests carried out at the users, to verify the effectiveness of Legit.Health Plus documentation in facilitating system Integration.

The objective of our testing is to determine if the provided documentation effectively assists users in achieving their goal of integrating Legit.Health Plus and addressing any potential issues that may arise during the process. This process is clearly outlined in R-TF-012-007 Software usability plan_2023_001.

The results conclusively demonstrate that the documentation successfully accomplishes its intended purpose.

Test checklist​

The following checklist verifies the completion of the goals and metrics specified in the requirement https://legithealth.atlassian.nethttps://legithealth.atlassian.net/wiki/spaces/LPDHF/pages/1219067932/REQ_012+We+facilitate+the+integration+of+the+device+into+the+users+system .

Requirement verification​

  • IFU and label validation is successful
  • GSPR are reviewed and we comply with requirements
  • Usability validation is successful

Evidence​

The medical device documentation is hosted in a GitHub repository.

evidence

It looks like the following and can be accessed at https://apidocs.legit.health/ :

evidence

The IFU and label validation was also performed with successful results can be found in R-TF-001-006 IFU and label validation 2023_001 and R-TF-008-001 General Safety Performance Requirements (GSPR) 2023_001.

Usability validation evidence can be found in R-TF-012-008 Software usability report_2023_001.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Tester: JD-017, JD-009, JD-004
  • Approver: JD-005
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TEST_010 The user specifies the body site of the skin structure
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TEST_012 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
  • Test type
  • Linked activities
  • Result
  • Description
  • Test checklist
    • Requirement verification
  • Evidence
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.)