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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
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      • Requirements
        • User Requirement Specification (URS)
          • URS-001 The user receives quantifiable data on the intensity of clinical signs
          • URS-002 The user receives quantifiable data on the count of clinical signs
          • URS-003 The user receives quantifiable data on the extent of clinical signs
          • URS-004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
          • URS-005 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
          • URS-006 The user receives the data in a format matching HL7 FHIR standard
          • URS-007 The user sees meaningful information about errors when something does not work
          • URS-008 The user knows if the image does not represent a skin structure
          • URS-009 The user knows if the image does not have enough quality for analysis
          • URS-010 The user knows the modality of the image
          • URS-011 The user specifies the body site of the skin structure
          • URS-012 Users can easily integrate the device into their system
          • URS-013 The user receives the pixel coordinates of possible ICD categories
          • URS-014 Users of the REST API can log in and receive an access token
        • Software Requirement Specification (SRS)
        • 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
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  • Legit.Health Plus Version 1.1.0.1
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  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements
  • User Requirement Specification (URS)

User Requirement Specification (URS)

📄️ URS-001 The user receives quantifiable data on the intensity of clinical signs

Source

📄️ URS-002 The user receives quantifiable data on the count of clinical signs

Category

📄️ URS-003 The user receives quantifiable data on the extent of clinical signs

Category

📄️ URS-004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image

Category

📄️ URS-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

📄️ URS-006 The user receives the data in a format matching HL7 FHIR standard

Category

📄️ URS-007 The user sees meaningful information about errors when something does not work

Category

📄️ URS-008 The user knows if the image does not represent a skin structure

Category

📄️ URS-009 The user knows if the image does not have enough quality for analysis

Category

📄️ URS-010 The user knows the modality of the image

Category

📄️ URS-011 The user specifies the body site of the skin structure

Category

📄️ URS-012 Users can easily integrate the device into their system

Category

📄️ URS-013 The user receives the pixel coordinates of possible ICD categories

Category

📄️ URS-014 Users of the REST API can log in and receive an access token

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URS-001 The user receives quantifiable data on the intensity of clinical signs
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