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QMSQMS
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 version 2.1 (Legacy MDD)
  • Legit.Health US Version 1.1.0.0
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
          • Request A: Clinical Data Analysis
            • Question
            • Research and planning
            • Response
            • Gap Analysis — Answers and Remediation Log
            • Information_for_answers
          • Request B: Data Sufficiency Justification
          • Message for Saray: PMS data clarifications (updated 2026-04-07)
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
        • completed-tasks
        • Coverage matrix
        • BSI Round-1 Submission: Export Plan
        • resources
        • scratchpad
      • Evidence rank & phases
      • Pre-submission review of R-TF-015-001 CEP and R-TF-015-003 CER
  • Pricing
  • Public tenders
  • Trainings
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 3: Clinical Data
  • Request A: Clinical Data Analysis
  • Question

Question

Please address all points above.

Please ensure all relevant clinical data is identified and provide sufficient analysis (including traceability, details, discussion and justifications).

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Item 3: Clinical Data
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Research and planning
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.)