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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File
      • Requirements
      • Test plans
      • Test runs
      • Review meetings
        • Design (Phase 1) Review
        • Design (Phase 2) Review
        • Software development review
        • Software verification review
        • Software validation review
      • 🥣 SOUPs
      • REL-001 Version 1.1.0.0
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Review meetings

Review meetings

📄️ Design (Phase 1) Review

General Information

📄️ Design (Phase 2) Review

📄️ Software development review

📄️ Software verification review

📄️ Software validation review

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TEST_018 Ensure API stability and cybersecurity of the medical device
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Design (Phase 1) 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.)