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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 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
        • Item 4: Usability
          • Question
          • Research and planning
          • Response
        • 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 4: Usability
  • Question

Question

Requirements and references​

  • GSPR 5
  • EN ISO 14971:2019 + A11:2022

MDF reference​

MDF4550 §3.2.4

Question​

Requirements​

  • GSPR 5 In eliminating or reducing risks related to use error, the manufacturer shall…
  • EN ISO 14971:2019 + A11:2022

Observations​

§20 of the CEP states that the summative usability validation will be conducted as an integral part of the upcoming clinical investigation. Further details are not found.

Request​

Please clarify what CI this refers to, and if it has been completed. Please provide a summary of the methodology (including users, sample size, critical tasks) and results.

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Message for Saray: PMS data clarifications (updated 2026-04-07)
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Research and planning
  • Requirements and references
  • MDF reference
  • Question
  • Requirements
  • Observations
  • Request
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