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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File
      • Requirements
        • User Requirement Specification (URS)
        • Software Requirement Specification (SRS)
          • SRS-001 The device handles user accounts through an internal user registration service
          • SRS-002 The REST API enforces HTTPS for all communications to ensure data security
          • SRS-003 The REST API implements rate limiting to prevent abuse
          • SRS-004 The REST API verifies the access token for every request to secure endpoints
          • SRS-005 Data exchanged with clinical endpoints of the API adhere to the FHIR standard
          • SRS-006 The REST API only accepts and outputs images in Base64 format
          • SRS-007 The diagnosis support service accepts multiple images to deliver more accurate results
          • SRS-008 The user's password is stored in the database as a hashed password
        • 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
      • Test plans
      • Test runs
      • Review meetings
      • 🥣 SOUPs
      • REL-001 Version 1.1.0.0
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements
  • Software Requirement Specification (SRS)

Software Requirement Specification (SRS)

📄️ SRS-001 The device handles user accounts through an internal user registration service

Category

📄️ SRS-002 The REST API enforces HTTPS for all communications to ensure data security

Category

📄️ SRS-003 The REST API implements rate limiting to prevent abuse

Category

📄️ SRS-004 The REST API verifies the access token for every request to secure endpoints

Category

📄️ SRS-005 Data exchanged with clinical endpoints of the API adhere to the FHIR standard

Category

📄️ SRS-006 The REST API only accepts and outputs images in Base64 format

Category

📄️ SRS-007 The diagnosis support service accepts multiple images to deliver more accurate results

Category

📄️ SRS-008 The user's password is stored in the database as a hashed password

Category

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URS-014 Users of the REST API can log in and receive an access token
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SRS-001 The device handles user accounts through an internal user registration service
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.)