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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • 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
        • Phase 1: Product Design Review
        • Phase 2: Software Design Review
        • Phase 3: Software Development Review (Release Candidate)
        • Phase 4: Software Verification Review
        • Phase 5: Product Validation Review
    • 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

📄️ Phase 1: Product Design Review

Process Overview

📄️ Phase 2: Software Design Review

Process Overview

📄️ Phase 3: Software Development Review (Release Candidate)

Process Overview

📄️ Phase 4: Software Verification Review

Process Overview

📄️ Phase 5: Product Validation Review

Process Overview

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R-TF-012-043 Traceability Matrix
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Phase 1: Product Design Review
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.)