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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 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
        • Item 3: Clinical Data
          • Request A: Clinical Data Analysis
          • Request B: Data Sufficiency Justification
            • Question
            • Research and planning
        • 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 3: Clinical Data
  • Request B: Data Sufficiency Justification
  • Question

Question

Please address all points above.

Please provide justification that sufficient data in quantity and quality has been analyzed in order to support the clinical benefit, safety, and performance of the device as compared to SotA in its intended use, including for all of the relevant patient populations and indications.

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Research and planning
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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.)