Index of Technical Documentation or Product File

For Legit.Health Plus Version 1.1.0.0

• Summary of Technical Documentation (STED)
• Description and specifications
• Declaration of conformity (DoC)
• 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
• Clinical
  • Evaluation
    • R-TF-015-001 Clinical Evaluation Plan
    • R-TF-015-002 Preclinical and Clinical Evaluation Record
    • R-TF-015-003 Clinical Evaluation Report
    • R-TF-015-007 Declaration of interest Clinical evaluation team
    • 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
    • MC_EVCDAO_2019
      • R-TF-015-005 Clinical investigation report
      • R-TF-015-005 Clinical investigation plan
    • DAO_Derivación_O_2022
      • R-TF-015-005 Clinical investigation report
      • R-TF-015-005 Clinical investigation plan
• Design and development
  • R-TF-012-006 Lifecycle plan and report
  • R-TF-012-007 Software usability plan
  • R-TF-012-008 Software usability report
  • R-TF-012-009 Validation and testing of machine learning processors
• Design History File (DHF)
  • Software Requirement Specification (SRS)
  • User Requirement Specification (URS)
  • Activity (ACT)
  • Test plan (PLAN)
  • Test run (TEST)
  • Version release (REL)
  • Change request (CHR)
• GSPR
  • R-TF-008-001 General Safety and Performance Requirements (GSPR)
• Post-Market surveillance
  • R-TF-007-001 Post-Market Surveillance (PMS) Plan
  • R-TF-007-002 Post-Market clinical follow-up (PMCF) Plan
  • R-TF-007-003 Periodic Safety Update Report (PSUR)
  • R-TF-007-004 PMS evaluation report
  • R-TF-007-005 PMCF evaluation report
• Risk management
  • R-TF-013-001 Risk management plan
  • R-TF-013-002 Risk management record
  • R-TF-013-003 Risk management report
• IFU and label
  • R-TF-001-006 IFU and label validation
  • R-TF-001-008 Label
  • IFU