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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
      • Product Requirement Specification (PRS)
      • Software Requirement Specification (SRS)
      • R-TF-012-019 SOUPs
      • R-TF-012-023 Software Development Plan
      • R-TF-012-030 Software Configuration Management Plan
      • Review meetings
      • R-TF-012-033 Software Tests Plan
      • R-TF-012-037 Labeling and IFU Requirements
      • deprecated
      • T-012-029 Software Architecture Description
      • R-TF-012-029 Software Architecture Description
      • R-TF-012-040 Documentation level FDA
      • R-TF-012-041 Software Classification 62304
      • R-TF-012-043 Traceability Matrix
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information

Design and Manufacturing Information

📄️ Product Requirement Specification (PRS)

📄️ Software Requirement Specification (SRS)

🗃️ R-TF-012-019 SOUPs

19 items

📄️ R-TF-012-023 Software Development Plan

Project plan

📄️ R-TF-012-030 Software Configuration Management Plan

Object

🗃️ Review meetings

5 items

📄️ R-TF-012-033 Software Tests Plan

Test identification

📄️ R-TF-012-037 Labeling and IFU Requirements

🗃️ deprecated

3 items

📄️ T-012-029 Software Architecture Description

Object

📄️ R-TF-012-029 Software Architecture Description

Object

📄️ R-TF-012-040 Documentation level FDA

Change history

📄️ R-TF-012-041 Software Classification 62304

Change history

📄️ R-TF-012-043 Traceability Matrix

Purpose

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Product Requirement Specification (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.)