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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
      • Commissioning
        • R-TF-029-001: Deployment and Configuration Commissioning Record
        • R-TF-029-002: Functional and Interface Commissioning Record
        • R-TF-029-003: Clinical Workflow and Operational Readiness Commissioning Record
    • 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
  • Commissioning

Commissioning

📄️ R-TF-029-001: Deployment and Configuration Commissioning Record

Document Control

📄️ R-TF-029-002: Functional and Interface Commissioning Record

Document Control

📄️ R-TF-029-003: Clinical Workflow and Operational Readiness Commissioning Record

Document Control

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Clinical strategy FDA 510(k) clearance for Legit.Health US version
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R-TF-029-001: Deployment and Configuration Commissioning Record
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.)