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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
    • 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
  • Index

Index

Index of Technical Documentation or Product File for Legit.Health Plus Version 1.1.0.0

Overview and Device Description​

  • Cover Letter
  • Summary of Technical Documentation (STED)
  • Description and specifications
  • Declaration of conformity (DoC)

Information Supplied by the Manufacturer​

  • R-TF-001-006 IFU and label validation
  • R-TF-001-008 Label
  • IFU
  • Promotional materials

Design and Manufacturing Information​

  • R-TF-012-019 SOUPs
  • R-TF-012-030 Software Configuration Management Plan
  • R-TF-012-028 Software Requirement Specification
  • R-TF-012-031 Product requirements specification (PRS)
  • R-TF-012-037 Labeling and IFU Requirements
  • R-TF-012-021 Product Design Phase 1 Checklist
  • R-TF-012-022 Software Design Phase 2 Checklist
  • R-TF-012-024 Software Candidate Release Phase 3 Checklist
  • R-TF-012-025 Software Verification Phase 4 Checklist
  • R-TF-012-026 Product Validation Phase 5 Checklist
  • R-TF-012-040 Documentation level FDA
  • R-TF-012-041 Software Classification 62304
  • R-TF-012-043 Traceability Matrix
  • R-TF-024-001 Software Bill of Material

GSPR​

  • R-TF-008-001 General Safety and Performance Requirements (GSPR)
  • R-TF-001-005 List of applicable standards and regulations

Benefit-Risk Analysis and Risk Management​

  • EN 14971 Checklist
  • 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-024-005 Security Risk Testing Report
  • R-TF-013-001 Risk management plan
  • R-TF-013-003 Risk management report
  • R-TF-013-002 Risk management record

Product Verification and Validation​

Software​

  • EN 62304 Checklist
  • EN 82304 Checklist
  • R-TF-012-023 Software Development Plan
  • R-TF-012-029 Software Architecture Description
  • R-TF-012-033 Software Test Plan
  • R-TF-012-034 Software Test Description
  • R-TF-012-035 Software Test Report
  • R-TF-012-038 Verified Version Release
  • R-TF-012-039 Validated Version Transfer
  • R-TF-012-006 Lifecycle plan and report
  • R-TF-029-001 Commissioning

Artificial Intelligence​

  • R-TF-028-001 AI/ML Description
  • R-TF-028-002 AI/ML Development Plan
  • R-TF-028-003 Data Collection Instructions
  • R-TF-028-004 Data Annotation Instructions
  • R-TF-028-005 AI/ML Development Report
  • R-TF-028-006 AI/ML Release
  • R-TF-028-007 AI/ML Retraining Report
  • R-TF-028-008 AI/ML Reevaluation Report
  • R-TF-028-009 AI/ML Design Checks
  • R-TF-028-010 AI/ML V&V Checks
  • R-TF-028-011 AI/ML Risk Matrix

Usability​

  • R-TF-025-001 Usability plan
  • R-TF-025-002 Identification of characteristics for safety and possible use errors
  • R-TF-025-003 User interface evaluation plan
  • R-TF-025-004 Summative evaluation protocol
  • R-TF-025-007 Summative evaluation report
  • EN 62366 Checklist

Clinical​

Evaluation​

  • R-TF-015-001 Clinical Evaluation Plan
  • R-TF-015-003 Clinical Evaluation Report
  • R-TF-015-007 Declaration of interest Clinical evaluation team
  • R-TF-015-008 Clinical development plan

Investigation​

  • COVIDX_EVCDAO_2022
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • MC_EVCDAO_2019
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • DAO_Derivación_O_2022
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • AIHS4 2025
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • BI 2024
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • DAO Derivación PH 2022
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • IDEI 2023
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • PH 2024
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155
  • SAN 2024
    • R-TF-015-005 Clinical investigation report
    • R-TF-015-005 Clinical investigation plan
    • Checklist Annex E ISO14155

Post-Market surveillance​

  • R-TF-007-001 Post-Market Surveillance (PMS) Plan
  • R-TF-007-002 Post-Market clinical follow-up (PMCF) Plan

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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Legit.Health Plus Version 1.1.0.0
Next
Overview and Device Description
  • Overview and Device Description
  • Information Supplied by the Manufacturer
  • Design and Manufacturing Information
  • GSPR
  • Benefit-Risk Analysis and Risk Management
  • Product Verification and Validation
    • Software
    • Artificial Intelligence
    • Usability
    • Clinical
      • Evaluation
      • Investigation
  • Post-Market surveillance
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.)