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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
          • ALADIN 2026
          • ADS TLD DAO 2025
          • AIHS4 2025
          • BI 2024
          • COVIDX EVCDAO 2022
          • DAO Derivación O 2022
          • DAO Derivación PH 2022
          • IDEI 2023
          • MC EVCDAO 2019
            • R-TF-015-004 Clinical investigation plan
            • R-TF-015-006 Clinical investigation report
            • R-TF-015-010 Annex E ISO 14155
          • PH 2024
          • SAN 2024
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
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  • Applicable Standards and Regulations
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  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Clinical
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  • MC EVCDAO 2019

MC EVCDAO 2019

📄️ R-TF-015-004 Clinical investigation plan

Scope

📄️ R-TF-015-006 Clinical investigation report

Research Title

📄️ R-TF-015-010 Annex E ISO 14155

ISO 14155:2020 Compliance Requirements

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R-TF-015-010 Annex E ISO 14155
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R-TF-015-004 Clinical investigation plan
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.)