Index

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

Overview and Device Description

• R-TF Summary of Technical Documentation (STED)
• R-TF Device Description and Specification
• R-TF-001-007 EU 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-012-028 Software Requirement Specification (SRS)
• R-TF-012-029 Software Architecture Description
• R-TF-012-030 Software Configuration Management Plan
• R-TF-012-031 Product requirements specification (PRS)
• 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

• 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

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

• R-TF-013-004 Checklist ISO 14971
• 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

• R-TF EN 62304 Checklist
• R-TF EN 82304 Checklist
• R-TF-012-023 Software Development Plan
• 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

Artificial Intelligence

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

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

Cyber Security

• R-TF-030-001 Cyber Security Management Plan
• R-TF-030-002 Software Bills Of Materials
• R-TF-030-003 Cyber Security Assessment Report
• R-TF-030-004 Cyber Security Risk Matrix
• R-TF-030-005 NIS2-Compliant Incident Response Plan

Clinical

Evaluation

• R-TF-015-001 Clinical Evaluation Plan
• R-TF-015-003 Clinical Evaluation Report
• R-TF-015-011 State of the Art

Investigation

• COVIDX_EVCDAO_2022
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-010 Checklist Annex E ISO14155
• MC_EVCDAO_2019
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-010 Checklist Annex E ISO14155
• DAO_Derivación_O_2022
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-010 Checklist Annex E ISO14155
• AIHS4 2025
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-010 Checklist Annex E ISO14155
• BI 2024
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-010 Checklist Annex E ISO14155
• DAO Derivación PH 2022
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-010 Checklist Annex E ISO14155
• IDEI 2023
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-010 Checklist Annex E ISO14155
• PH 2024
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-010 Checklist Annex E ISO14155
• SAN 2024
  • R-TF-015-005 Clinical investigation report
  • R-TF-015-004 Clinical investigation plan
  • R-TF-015-010 Checklist Annex E ISO14155

Commissioning

• R-TF-029-001 Deployment and Configuration Commissioning Record
• R-TF-029-002 Functional and Interface Commissioning Record
• R-TF-029-003 Clinical Workflow and Operational Readiness Commissioning Record

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 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager