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QMS
  • 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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    • Design and development
    • Design History File
      • Requirements
        • User Requirement Specification (URS)
        • 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

Requirements

🗃️ User Requirement Specification (URS)

14 items

🗃️ Software Requirement Specification (SRS)

8 items

📄️ 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

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Design History File
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User Requirement Specification (URS)
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