Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
      • Software
      • Artificial Intelligence
      • Cybersecurity
      • Usability and Human Factors Engineering
      • Clinical
        • Evaluation
        • Investigation
          • 🗄 Drafts
          • AFF_2026
          • ALADIN 2026
          • AVASI_2026
          • AWOSI_2026
          • ICD_DXP_2026
          • Sant_Pau_2024
          • VH_clinical_2025
          • VH_triaje_2025
          • aEASI_HVN_2026
          • ADS TLD DAO 2025
          • AIHS4 2025
          • BI 2024
          • COVIDX EVCDAO 2022
          • DAO Derivación O 2022
          • DAO Derivación PH 2022
          • IDEI 2023
          • MAN 2025
            • R-TF-015-004 Clinical investigation plan
            • R-TF-015-006 Clinical investigation report
            • R-TF-015-010 Annex E ISO 14155
          • MC EVCDAO 2019
          • PH 2024
          • SAN 2024
        • Legit.Health-US-version-1-1-0-0
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health version 2.1 (Legacy MDD)
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Clinical
  • Investigation
  • MAN 2025
  • R-TF-015-010 Annex E ISO 14155

R-TF-015-010 Annex E ISO 14155

ISO 14155:2020 Compliance Requirements​

This section documents compliance with ISO 14155:2020 requirements for clinical investigations of medical devices. The table below provides a comprehensive checklist of documentation required under ISO 14155 and indicates which documents have been provided or prepared for this clinical investigation.

Previous
R-TF-015-006 Clinical investigation report
Next
MC EVCDAO 2019
  • ISO 14155:2020 Compliance Requirements
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.)