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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
      • R-TF-012-019 SOUPs
      • R-TF-012-028 Software Requirement Specification
      • R-TF-012-029 Software Architecture Description
      • R-TF-012-030 Software Configuration Management Plan
      • R-TF-012-031 Product requirements specification
      • R-TF-012-037 Labeling and IFU Requirements
      • R-TF-012-040 Documentation level FDA
      • R-TF-012-041 Software Classification 62304
      • R-TF-012-043 Traceability Matrix
      • Review meetings
        • R-TF-012-021 Product Design Phase 1 Checklist
        • R-TF-012-022 Software Design Phase 2 Checklist
        • R-TF-012-024 Software Candidate Release Phase 3 Checklist
        • R-TF-012-025 Software Verification Phase 4 Checklist
        • R-TF-012-026 Product Validation Phase 5 Checklist
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information
  • Review meetings

Review meetings

📄️ R-TF-012-021 Product Design Phase 1 Checklist

Process Overview

📄️ R-TF-012-022 Software Design Phase 2 Checklist

Process Overview

📄️ R-TF-012-024 Software Candidate Release Phase 3 Checklist

Process Overview

📄️ R-TF-012-025 Software Verification Phase 4 Checklist

Process Overview

📄️ R-TF-012-026 Product Validation Phase 5 Checklist

Process Overview

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R-TF-012-043 Traceability Matrix
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R-TF-012-021 Product Design Phase 1 Checklist
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.)