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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
    • GSPR
    • Benefit-Risk Analysis and Risk Management
      • R-TF-013-001 Risk management plan
      • R-TF-013-002 Risk management record
      • R-TF-013-003 Risk management report
      • R-TF-024-001 Software Bills Of Materials
      • R-TF-024-002 Cyber Security Risk Management Plan
      • R-TF-024-003 Cyber Security Risk Matrix
      • R-TF-024-004 Security Risk Assessment Report
      • R-TF-025-005 Security Risk Testing Report
      • T-024-006 Threat Model Document
      • T-024-007 Cybersecurity Post-Market Surveillance Plan
      • T-024-009 Security Architecture Document
    • 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
  • Benefit-Risk Analysis and Risk Management

Benefit-Risk Analysis and Risk Management

📄️ R-TF-013-001 Risk management plan

Scope

📄️ R-TF-013-002 Risk management record

This record is carried out following the procedure GP-013 Risk management and according to R-TF-013-001 Risk management plan, which is also carried out following GP-013. The definition of the risk control options, the risk levels, risk acceptability and everything else, can be found in GP-013 Risk management.

📄️ R-TF-013-003 Risk management report

Intended use and identification of the qualitative and quantitative characteristics

📄️ R-TF-024-001 Software Bills Of Materials

📄️ R-TF-024-002 Cyber Security Risk Management Plan

Scope

📄️ R-TF-024-003 Cyber Security Risk Matrix

Security Risk Assessment

📄️ R-TF-024-004 Security Risk Assessment Report

Scope

📄️ R-TF-025-005 Security Risk Testing Report

Provide a link to the security risk testing report, which should have the following sections:

📄️ T-024-006 Threat Model Document

Executive Summary

📄️ T-024-007 Cybersecurity Post-Market Surveillance Plan

Executive Summary

📄️ T-024-009 Security Architecture Document

Executive Summary

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R-TF-008-001 General Safety and Performance Requirements (GSPR)
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R-TF-013-001 Risk management plan
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.)