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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-012-028 Software Requirement Specification
      • R-TF-012-029 Software Architecture Description
      • R-TF-012-030 Software Configuration Management Plan
      • R-TF-012-031 Product requirements specification
      • R-TF-012-033 Software Tests Plan
      • R-TF-012-037 Labeling and IFU Requirements
      • R-TF-012-040 Documentation level FDA
      • R-TF-012-041 Software Classification 62304
      • R-TF-012-043 Traceability Matrix
      • Review meetings
    • 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

🗃️ R-TF-012-019 SOUPs

17 items

📄️ R-TF-012-028 Software Requirement Specification

📄️ R-TF-012-029 Software Architecture Description

Introduction

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

Object

📄️ R-TF-012-031 Product requirements specification

📄️ R-TF-012-033 Software Tests Plan

Test identification

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

📄️ 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

🗃️ Review meetings

5 items

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R-TF-012-019 SOUPs
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.)