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QMS
  • Welcome to your QMS
  • Quality Manual
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  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
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    • R-TF-001-007 Declaration of conformity
    • GSPR
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    • Design and development
    • Design History File (DHF)
      • Version 1.0.0.0
        • 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
        • 🥣 SOUPs
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  • Licenses and accreditations
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  • TF_Legit.Health_Plus
  • Design History File (DHF)
  • Version 1.0.0.0
  • Test runs

Test runs

📄️ TEST_001 The user receives quantifiable data on the intensity of clinical signs

Test type

📄️ TEST_002 The user receives quantifiable data on the count of clinical signs

Test type

📄️ TEST_003 The user receives quantifiable data on the extent of clinical signs

Test type

📄️ TEST_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image

Test type

📄️ TEST_007 If something does not work, the API returns meaningful information about the error

Test type

📄️ TEST_008 Notify the user image modality and if the image does not represent a skin structure

Test type

📄️ TEST_009 Notify the user if the quality of the image is insufficient

Test type

📄️ TEST_010 The user specifies the body site of the skin structure

Test type

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

Test type

📄️ 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

This test run has been replaced by TEST014, TEST015 and TEST_018.

📄️ TEST_013 The data that users send and receive follows the FHIR healthcare interoperability standard

Test type

📄️ TEST-014 The user authentication feature is functioning correctly

Test type

📄️ TEST_015 Ensure all API communications are conducted over HTTPS

Test type

📄️ TEST_016 Ensure API compliance with Base64 image format and FHIR standard

Test type

📄️ TEST_017 Verification of authorized user registration and body zone specification in device API

Test type

📄️ TEST_018 Ensure API stability and cybersecurity of the medical device

Test type

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TEST_001 The user receives quantifiable data on the intensity of clinical signs
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.)