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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
          • Request A: Device Description & Intended Purpose
            • Question
            • Research and planning
          • Request B: Clinical Benefits, Performance & Safety vs SotA
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 2: Device Description & Claims
  • Request A: Device Description & Intended Purpose
  • Question

Question

Observations​

The device description and intended purpose/indications remain unclear:

For example:

  • What is the list of possible ICD categories relevant to the device
  • What are the specific indications (including the comprehensive list of the specific malignant/high risk diseases this device may be used for)?
  • What are the specific outputs of the device (probability of a disease, ICD category, specific recommendations, etc)

Request​

Please address all points above.

Please provide a clear and comprehensive device description, intended purpose and indication in order to demonstrate compliance with Annex II and Annex XIV 1 (a), sub-bullets 2 and 3.

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Item 2: Device Description, Intended Purpose/Indications, Claims
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Research and planning
  • Observations
  • Request
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.)