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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • 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-012-037 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
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information

Design and Manufacturing Information

🗃️ R-TF-012-019 SOUPs

25 items

📄️ R-TF-012-028 Software Requirement Specification

📄️ R-TF-012-029 Software Architecture Description

Purpose

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

Purpose

📄️ R-TF-012-031 Product requirements specification

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

This document specifies the labeling and Instructions for Use (IFU) requirements for Legit.Health Plus. These requirements are derived from the risk management process documented in R-TF-013-002 Risk Management Record and ensure that adequate information is provided to users to mitigate identified risks through proper labeling and documentation.

📄️ 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.)