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    • Design History File (DHF)
      • Version 1.0.0.0
        • Requirements
          • REQ_001 The user receives quantifiable data on the intensity of clinical signs
          • REQ_002 The user receives quantifiable data on the count of clinical signs
          • REQ_003 The user receives quantifiable data on the extent of clinical signs
          • REQ_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
          • REQ_005 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
          • REQ_006 The data that users send and receive follows the FHIR healthcare interoperability standard
          • REQ_007 If something does not work, the API returns meaningful information about the error
          • REQ_008 Notify the user if the image does not represent a skin structure
          • REQ_009 Notify the user if the quality of the image is insufficient
          • REQ_010 The device detects if the image is of clinical or dermatoscopic modality
          • REQ_011 The user specifies the body site of the skin structure
          • REQ_012 Users can easily integrate the device into their system
          • REQ_013 The user receives the pixel coordinates of possible ICD categories
          • ignore-this
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  • TF_Legit.Health_Plus
  • Design History File (DHF)
  • Version 1.0.0.0
  • Requirements

Requirements

📄️ REQ_001 The user receives quantifiable data on the intensity of clinical signs

Category

📄️ REQ_002 The user receives quantifiable data on the count of clinical signs

Category

📄️ REQ_003 The user receives quantifiable data on the extent of clinical signs

Category

📄️ REQ_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image

Category

📄️ REQ_005 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner

Category

📄️ REQ_006 The data that users send and receive follows the FHIR healthcare interoperability standard

Category

📄️ REQ_007 If something does not work, the API returns meaningful information about the error

Category

📄️ REQ_008 Notify the user if the image does not represent a skin structure

Category

📄️ REQ_009 Notify the user if the quality of the image is insufficient

Category

📄️ REQ_010 The device detects if the image is of clinical or dermatoscopic modality

Category

📄️ REQ_011 The user specifies the body site of the skin structure

Category

📄️ REQ_012 Users can easily integrate the device into their system

Category

📄️ REQ_013 The user receives the pixel coordinates of possible ICD categories

Category

🗃️ ignore-this

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REQ_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.)