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