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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
        • PRS
        • Deprecated Software Requirement Specification (SRS)
        • Software Requirement Specification (SRS)
        • missing-documents
      • Test plans
      • Test runs
      • Review meetings
      • 🥣 SOUPs
      • REL-001 Version 1.1.0.0
    • IFU and label
    • Post-Market Surveillance
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    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
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  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements

Requirements

📄️ PRS

PRS-001: Generate an interpretative probability distribution of possible ICD categories by analysing images

🗃️ Deprecated Software Requirement Specification (SRS)

8 items

🗃️ Software Requirement Specification (SRS)

54 items

📄️ missing-documents

Product Design Phase 1 Checklist.

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Design History File
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PRS
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.)