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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
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Design History File
      • Requirements
        • Deprecated Software Requirement Specification (SRS)
        • missing-documents
      • Test plans
      • Test runs
      • Review meetings
      • REL-001 Version 1.1.0.0
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements
  • missing-documents

missing-documents

Product Design Phase 1 Checklist. Software Design Phase 2 Checklist. Documentation level FDA PHA Checklist Security Risk Management Plan Security Risk Matrix AI/ML Description AI/ML Development Plan Data Collection Instructions Data Annotation Instructions SF14.20_Regulatory Requirement SF26.02_Security Risk Assessment Report SF15.01_Commissioning Checklist

SF14.03_Software Requirement Specification SF14.04 Software Tests Plan SF14.05_Software Architecture Description SF14.06_Software Test Report SF14.10_Version delivery description (Design transfer) SF14.11_Software configuration management plan SF14.12_Software Test Description SF14.13_Software Detailed Design (class c) SF14.14_Traceability Matrix SF14.15_Documentation level FDA SF14.16_Software Classification 62304 SF14.17_Product requirements SF14.18_Device Description SF14.19_Intended use SF14.20_Regulatory Requirement SF14.21 SOUP List

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SRS-008 The user's password is stored in the database as a hashed password
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Test plans
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.)