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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
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
          • Request A: PMCF Activity Descriptions
          • Request B: PMCF Data Sufficiency Justification
            • Question
            • Research and planning
        • Item 7: Risk
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 6: PMCF Plan
  • Request B: PMCF Data Sufficiency Justification
  • Question

Question

Please address all points above.

Please provide a justification that the planned activities will collect sufficient data on safety and performance of the device throughout its lifetime.

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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.)