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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
      • Round 1
        • M1: Diagnostic Function
        • M2: Software V&V
        • N1: Information Supplied
        • N2: Usability
          • Qa: RCA & Residual Risk
          • Qb: Intended Use Misunderstanding
            • Question
            • Research and planning
            • Response
          • Qc: IFU Usability Results
          • Qd: Safety Information Effectiveness
        • N3: Risk Management
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Technical Review
  • Round 1
  • N2: Usability
  • Qb: Intended Use Misunderstanding
  • Question

Question

It is unclear why it was acceptable that 33% of HCP participants did not understand that the device is not intended for diagnosis. Risks R-TBN "Insufficient label information to understand the device intended use, version" and R-CGQ "Whole device is wrongly used or is not used as intended" are not clearly effectively mitigated.

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Research and planning
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