Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
    • Legit.Health Plus STED
    • Legit.Health Plus description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • 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
        • Test plans
        • Test runs
        • 🥣 SOUPs
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • TF_Legit.Health_Plus
  • Design History File (DHF)
  • Version 1.0.0.0
  • Requirements
  • REQ_011 The user specifies the body site of the skin structure

REQ_011 The user specifies the body site of the skin structure

Category​

Major

Source​

  • Alfonso Medela JD-005

USER DATABASE AND DATA DEFINITION SYSTEM INPUTS AND OUTPUTS ARCHITECTURE

Activities generated​

  • MDS-453

Causes failure modes​

  • Users enter non-existent or anatomically incorrect body sites.
  • Users input the wrong body site due to typos or misunderstandings.
  • Users specify body sites in an ambiguous manner, leading to confusion (e.g., "arm" instead of "left forearm").
  • Lack of documentation, guidance or prompts to help users accurately specify the body site.
  • Errors in mapping user-specified body sites to the system’s internal representation.
  • The system does not or incorrectly validate user input for body sites, allowing invalid entries to pass through.

Related risks​

    1. The endpoints of the device are not compatible with the user's software
    1. Medical device input requirements are not defined to users to its proper operation
    1. Inadequate specification of the product intended purpose.

User Requirement, Software Requirement Specification and Design requirement​

  • User Requirement 11.1: Users must be able to specify the body site of the skin structure in the request.
  • Software Requirement Specification 11.2: The device must accept and process input regarding the body site of the skin structure in relation to the submitted image.
  • Design Requirement 11.3: Ensure device request formatting allows for clear and standardised submission of body site data in line with healthcare data standards.

Description​

Just as age and sex hold significance in clinical diagnoses and medical assessments within the field of dermatology, the location on the body, referred to as "body sites," is equally vital. Dermatological conditions often manifest with varying visual characteristics depending on the specific body site, and their prevalence can differ accordingly. For instance, acne predominantly appears on the face in most cases.

Within this requirement, our focus lies in providing users with the means to specify the precise body site related to a skin structure. This task extends beyond merely introducing a data field; it entails the creation of a taxonomy that is both user-friendly and practical for the device. The taxonomy categorizes body sites hierarchically, commencing with the broad category of the whole body and progressively branching into more specific locations like the head, face, mouth, and lips. The finalized taxonomy will be available in our documentation, ensuring clarity and ease of use.

Success metrics​

GoalMetric
User can specify body site of the skin structureMedical device accepts body sites in the request

Previous related requirements​

  • REQ_005

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Tester: JD-017, JD-009, JD-005, JD-004
  • Approver: JD-003
Previous
REQ_010 The device detects if the image is of clinical or dermatoscopic modality
Next
REQ_012 Users can easily integrate the device into their system
  • Category
  • Source
  • Activities generated
  • Causes failure modes
  • Related risks
  • User Requirement, Software Requirement Specification and Design requirement
  • Description
  • Success metrics
  • Previous related requirements
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.)