Legit.Health Plus TF index

• Legit.Health Plus STED_2023_001
• Legit.Health Plus description and specifications 2023_001
• R-TF-001-007 Declaration of conformity
• Clinical
  • Evaluation
    • R-TF-015-001 Clinical Evaluation Plan_2023_001
    • R-TF-015-002 Preclinical and Clinical Evaluation Record_2023_001
    • R-TF-015-003 Clinical Evaluation Report_2023_001
    • R-TF-015-007 Declaration of interest Clinical evaluation team_2023_001
    • R-TF-015-007 Declaration of interest Clinical evaluation team_2023_002
  • Investigation
    • R-TF-015-004 Clinical investigation plan_LEGIT_COVIDX_EVCDAO_2022
    • R-TF-015-004 Clinical investigation plan_LEGIT_MC_EVCDAO_2019
    • R-TF-015-004 Clinical investigation plan_LEGIT.HEALTH_DAO_Derivación_O_2022
    • R-TF-015-006 Clinical investigation report_LEGIT.HEALTH_DAO_Derivación_O_2022
    • R-TF-015-006 Clinical investigation report_LEGIT_COVIDX_EVCDAO_2022
    • R-TF-015-006 Clinical investigation report_LEGIT_MC_EVCDAO_2019
  • R-TF-015-008 Clinical development plan_2023_002
• Design and development
  • R-TF-012-001 Requirements 2023_001
  • R-TF-012-002 Activities 2023_001
  • R-TF-012-003 Tests 2023_001
  • R-TF-012-004 Release v1.0
  • R-TF-012-005 Design change control 2023_001
  • R-TF-012-006 Lifecycle plan and report_2023_001
  • R-TF-012-007 Software usability plan_2023_001
  • R-TF-012-008 Software usability report_2023_001
  • R-TF-012-009 Validation and testing of machine learning processors_2023_001
• GSPR
  • R-TF-008-001 GSPR 2023_001
• Post-Market surveillance
  • R-TF-007-001 Post-Market Surveillance (PMS) Plan_2023_001
  • R-TF-007-002 Post-Market clinical follow-up (PMCF) Plan_2023_001
  • R-TF-007-003 Periodic Safety Update Report (PSUR) 2023_001
  • R-TF-007-004 PMS evaluation report_2023_001
  • R-TF-007-005 PMCF evaluation report_2023_001
• Risk management
  • R-TF-013-001 Risk management plan_2023_001
  • R-TF-013-002 Risk management record_2023_001
  • R-TF-013-003 Risk management report_2023_001
• IFU and label
  • R-TF-001-006 IFU and label validation 2023_001
  • R-TF-001-008 Legit.Health Plus label 2023_001
  • IFU