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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
      • R-TF-012-019 SOUPs
      • R-TF-012-030 Software Configuration Management Plan
      • Software Requirement Specification (SRS)
      • Product Requirement Specification (PRS)
      • R-TF-012-037 Labeling and IFU Requirements
      • deprecated
      • Usability engineering file
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Design History File
    • 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 and Manufacturing Information
  • R-TF-012-037 Labeling and IFU Requirements

R-TF-012-037 Labeling and IFU Requirements

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Product Requirement Specification (PRS)
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R-TF-012-009 Validation and testing of machine learning models
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.)