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QMS
  • Welcome to your QMS
  • Quality Manual
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  • 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
        • 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
        • R-TF-012-033 Software Tests Plan
        • R-TF-012-023 Software Development Plan
        • EN 62304 Checklist
        • EN 82304 Checklist
        • R-TF-012-029 Software Architecture Description
        • R-TF-012-034 Software Test Description
        • R-TF-012-035 Software Test Report
        • R-TF-012-038 Verified Version Release
        • Design History File
      • Artificial Intelligence
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      • Usability and Human Factors Engineering
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  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
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  • TEST_010 The user specifies the body site of the skin structure

TEST_010 The user specifies the body site of the skin structure

Test type​

System

Linked activities​

  • MDS-453

Result​

  • Passed
  • Failed

Description​

Tests carried out at the receiver component, to verify that users can specify the body site of the skin structure.

Objective​

The objective is to enable users to submit information about the body site of the skin structure, thereby offering supplementary and valuable data for the clinical algorithm's analysis.

Acceptance criteria​

Medical device accepts body sites in the request.

Materials & methods​

First, we established a taxonomy for encoding within the medical device.

HEAD_TOP
HEAD_FRONT
HEAD_BACK
HEAD_LEFT
HEAD_RIGHT
ARM_LEFT
ARM_RIGHT
TRUNK_FRONT
TRUNK_BACK
LEG_LEFT
LEG_RIGHT
HAND_LEFT
HAND_RIGHT
FOOT_LEFT
FOOT_RIGHT
GENITAL
SCALP
EAR_LEFT
EAR_RIGHT
PERIORAL
TONGUE
ELBOW_LEFT
ELBOW_RIGHT
UPPER_ARM_LEFT
UPPER_ARM_RIGHT
LOWER_ARM_LEFT
LOWER_ARM_RIGHT
KNEE_LEFT
KNEE_RIGHT
UPPER_LEG_LEFT
UPPER_LEG_RIGHT
LOWER_LEG_LEFT
LOWER_LEG_RIGHT

Subsequently, we devised a method that adheres to the FHIR standard, ensuring user-friendly interaction with the device. Users can incorporate the body site information under the bodySite key within the payload.

Results​

The receiver accurately handles body site data and transmits it to the orchestrator.

Protocol deviations​

There were no deviations from initial protocol.

Conclusions​

Users can interact with the device by submitting the body site where the lesion is located.

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/1219395593/REQ_011+The+user+specifies+the+body+site+of+the+skin+structure .

Requirement verification​

  • Medical device accepts body sites in the request

Evidence​

The following request includes the HEAD_BACK body site and the output score is 10.5.

evidence

evidence

A different result is obtained if we send the same image with the TRUNK_FRONT body site:

evidence

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_009 Notify the user if the quality of the image is insufficient
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TEST_011 We facilitate the integration of the device into the users' system
  • Test type
  • Linked activities
  • Result
  • Description
    • Objective
    • Acceptance criteria
    • Materials & methods
    • Results
    • Protocol deviations
    • Conclusions
  • 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.)