R-TF-012-043 Traceability Matrix
Purpose
This traceability matrix establishes the complete bidirectional relationships between risks, requirements, design specifications, and testing activities for Legit Health Plus v1.1.0.0, in accordance with IEC 62304 clauses 5.1.1, 5.1.9, 5.5.3, and 8.2.4.
The matrix ensures compliance with IEC 62304 by demonstrating that:
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Risk Traceability (IEC 62304 § 7.1, 7.2; ISO 14971 § 6.2, 7.1, 7.3, 8): All identified risks in document R-TF-013-002 have been addressed by:
- Software requirements designed to mitigate the risk (risk control measures)
- Software requirements which introduced or contribute to the risk
- Verification of implementation of risk controls (ISO 14971 § 7.1) - confirming that risk control measures have been implemented as specified in the design
- Verification of effectiveness of risk controls (ISO 14971 § 7.3, 8) - confirming that the implemented risk control measures actually reduce the identified risk to an acceptable level and evaluation of residual risk
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Requirements Traceability (IEC 62304 § 5.1.1, 5.1.9):
- All software requirements (SRS) are traced to their source:
- Product requirements (PR) from system-level specifications
- Regulatory requirements (RR) from applicable standards and regulations
- All product requirements are implemented by one or more software requirements
- Changes to requirements can be traced to their impact on design and testing
- All software requirements (SRS) are traced to their source:
-
Verification Traceability (IEC 62304 § 5.5, 5.6):
- All software requirements are verified through defined test cases
- All test cases are linked to specific software requirements
- Test execution results are documented with pass/fail status
- Verification activities are appropriate to the software safety class (Class C)
-
Completeness and Coverage Analysis (IEC 62304 § 5.7, 5.8):
- No software requirement exists without verification
- No risk exists without mitigation or acceptance
- No test case exists without traceability to requirements
- Coverage gaps are identified, analyzed, and addressed
Scope
This traceability matrix covers:
- Risks: Identified in [R-TF-013-002 Risk management record]
- Product Requirements (PR): Documented in [R-TF-012-001 Product Requirements]
- Software Requirements (SRS): Documented in [R-TF-012-028 Software Requirement Specification]
- Regulatory Requirements (RR): Documented in [R-TF-012-037 Labeling and IFU Requirements]
- Test Cases: Documented in [R-TF-012-033 Software Tests Plan] and [R-TF-012-034 Software Test Description]
Change History
Product: Legit Health Plus Version: 1.1.0.0
Part 1: Risk Traceability to Software Requirements
Reference to Risk Management Documentation
In accordance with IEC 62304 § 7.1 (Risk analysis of software contributing to hazardous situations) and ISO 14971 § 6.2 (Risk control measures), the complete traceability between identified risks and their corresponding software requirement specifications (SRS) is documented in R-TF-013-002 Risk Management Record.
Rationale for Document Separation
This traceability matrix does not duplicate the risk-to-SRS traceability information for the following regulatory and practical reasons:
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Single Source of Truth (ISO 13485 § 4.2.4): Maintaining traceability information in a single authoritative document (the Risk Management Record) ensures data integrity, prevents inconsistencies, and facilitates change control. The Risk Management Record serves as the primary source for all risk-related traceability.
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ISO 14971 § 3.5 Compliance: ISO 14971 requires a risk management file that contains comprehensive risk analysis documentation. Concentrating risk traceability within R-TF-013-002 ensures all risk control measure information, including:
- Risk identification and characterization
- Risk control measure selection and implementation (ISO 14971 § 6.2, 7.1)
- Verification of risk control implementation (ISO 14971 § 7.1)
- Verification of risk control effectiveness (ISO 14971 § 7.3)
- Residual risk evaluation (ISO 14971 § 7.4)
is maintained in a centralized, auditable format.
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Document Maintainability (IEC 62304 § 5.1.1): Avoiding duplication reduces the risk of:
- Version conflicts between documents
- Incomplete updates when requirements or risk assessments change
- Increased review and approval burden
- Confusion during regulatory inspections or audits
-
Readability and Usability: By referencing rather than duplicating, this document remains focused on its core purpose: demonstrating the traceability from product requirements through software requirements to verification activities. This structure allows:
- Easier navigation for reviewers and auditors
- Clearer separation of concerns between risk management and requirements management
- More efficient document maintenance and version control
-
IEC 62304 § 5.1.9 Compliance: This clause requires maintaining traceability between different levels of requirements and to risk controls. This requirement is satisfied through the combination of:
- Risk-to-SRS traceability in R-TF-013-002
- PR-to-SRS and SRS-to-Test traceability in this document (Parts 2 and 3)
Together, these documents provide complete bidirectional traceability without redundancy.
Continuous Integration Between Documents
The relationship between R-TF-013-002 (Risk Management Record) and R-TF-012-043 (Traceability Matrix) is continuous and dynamic throughout the product development lifecycle governed by GP-012 (Design and Development Process):
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Forward Flow - Development Phase:
- Software requirements (SRS) are defined to address identified risks and product requirements
- Test cases are created to verify SRS implementation (documented in this matrix - Parts 2 and 3)
- As SRS are implemented and tested, this information flows back to R-TF-013-002
- The Risk Management Record is continuously updated to reflect:
- Implementation status of risk control measures
- Verification of risk control implementation (ISO 14971 § 7.1)
- Links to specific test cases that verify risk controls
-
Backward Flow - Post-Market and Clinical Evaluation:
- Verification of risk control effectiveness (ISO 14971 § 7.3, 8) requires real-world evidence from:
- Clinical evaluation data (ISO 14155, MDR Annex XIV)
- Post-market surveillance data (ISO 14971 § 9)
- Clinical performance data
- This column in the Risk Management Record cannot be completed until clinical evaluation activities have generated sufficient evidence
- The effectiveness verification is therefore a post-development activity that confirms residual risk acceptability
- Verification of risk control effectiveness (ISO 14971 § 7.3, 8) requires real-world evidence from:
-
Process Centralization (GP-012):
- While GP-012 (Design and Development) is the central coordinating process for product development
- Multiple processes operate in parallel:
- GP-001 (Risk Management) - maintains R-TF-013-002
- GP-003 (Clinical Evaluation) - provides effectiveness data
- GP-008 (Post-Market Surveillance) - provides real-world performance data
- GP-012 orchestrates the information flow between these processes to ensure:
- Risk control measures are implemented in design
- Verification activities are completed before release
- Effectiveness evaluation is planned and executed post-market
- Traceability remains current throughout the product lifecycle
This integrated approach ensures that risk management is not a one-time activity but a continuous process (ISO 14971 § 9, IEC 62304 § 9.1) where design outputs feed into risk assessment and post-market data feeds back into risk control effectiveness evaluation.
What is Documented Here
This traceability matrix (R-TF-012-043) focuses on:
- Part 2: Product Requirements (PR) to Software Requirements (SRS) traceability
- Part 3: Software Requirements (SRS) to Test Cases and Test Results traceability
For comprehensive risk-to-requirement traceability, including risk control measures, implementation verification, and effectiveness evaluation, refer to R-TF-013-002 Risk Management Record.
Part 2: Product Requirements to Software Requirements
This section traces product requirements to their implementing software requirements, ensuring that all product-level needs are addressed in the software design.
| Code | Name | Derived from Product Requirements |
|---|---|---|
| SRS-Q3Q | Generate an aggregated ICD probability distribution from a set of images |
|
| SRS-0AB | Generate per-image ICD analysis with explainability heat map |
|
| SRS-58W | Include entropy score in report |
|
| SRS-71I | Include the indicator of needing a high priority referral in the report |
|
| SRS-8HY | Include the indicator of malignancy in the report |
|
| SRS-D08 | Include the indicator of the image presenting a pigmented lesion in the report |
|
| SRS-JLM | Include the indicator of the presence of a condition in the report |
|
| SRS-KAS | Include the indicator of needing an urgent referral in the report |
|
| SRS-K7M | Orchestrate diagnosis support workflow |
|
| SRS-7PJ | Network Service Exposure |
|
| SRS-AQM | Standard HTTP Status Code Usage |
|
| SRS-BYJ | JSON Data Interchange Format |
|
| SRS-DW0 | User Authentication Endpoint Implementation |
|
| SRS-D3N | Provision of Clinical Parameter Endpoints |
|
| SRS-LBS | URL-Based API Versioning |
|
| SRS-MZC | Request Body Size Limitation |
|
| SRS-Q9M | Clinical Signs Analysis Endpoint Implementation |
|
| SRS-RXK | Diagnostic Support Endpoint Implementation |
|
| SRS-ZQO | Concurrent API Version Support |
|
| SRS-6KE | API Health Check Endpoint |
|
| SRS-BA6 | Display the legal information about this medical device |
|
| SRS-Z24 | API Documentation Endpoint |
|
| SRS-ID7 | Input Data Validation |
|
| SRS-EH4 | Security-Safe Error Handling |
|
| SRS-1KW | Secure Communication Protocol Enforcement |
|
| SRS-28X | Implement progressive delays between failed login attempts |
|
| SRS-A25 | Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions |
|
| SRS-A2B | API Rate Limiting |
|
| SRS-MM8 | Generated JWTs must have an expiration date |
|
| SRS-SDZ | Use hashed and salted passwords |
|
| SRS-TPK | Lock accounts after five failed attempts |
|
| SRS-U8M | Enforce strong password policies (min. 12 characters, complexity rules, expiration policies) |
|
| SRS-WER | Endpoint Access Control |
|
| SRS-WGF | AES-256 encryption for data at rest |
|
| SRS-X9J | Conduct periodic access reviews to verify permissions align with job functions |
|
| SRS-IC4 | Software and Configuration Integrity Verification |
|
| SRS-BK7 | Encrypted Backup and Integrity Verification |
|
| SRS-CCD | Intrusion Prevention and Malicious Traffic Detection |
|
| SRS-F05 | Generate FHIR DiagnosticReport Base Structure |
|
| SRS-FMG | Record Analysis Duration in Report |
|
| SRS-JC6 | The product provides a final image validity summary |
|
| SRS-K6N | Map Per-Image Analysis to a dedicated object in the report |
|
| SRS-H3J | Deterministic Response Schemas |
|
| SRS-W5Z | Assign DiagnosticReport Identifier |
|
| SRS-BWB | Performance and Latency |
|
| SRS-GER | System Behavior on Internal Component Failure. |
|
| SRS-HUG | Traceability via Correlation Identifiers |
|
| SRS-D6W | Accurate Time Synchronization |
|
| SRS-PU2 | Comprehensive Event Auditing |
|
| SRS-SI2 | Secure Audit Trail Access Interface |
|
| SRS-T5P | Audit Record Integrity Protection |
|
| SRS-T95 | Audit System Failure Handling |
|
| SRS-U2P | Consolidated Audit Record Content |
|
| SRS-A9F | Wound Bed Tissue - Epithelial |
|
| SRS-B3Z | Inflammatory Pattern Identification |
|
| SRS-B6L | Wound Bed Tissue - Necrotic |
|
| SRS-B8N | Pustule Intensity Quantification |
|
| SRS-A4W | Inflammatory Nodular Lesion Quantification |
|
| SRS-A6T | Delimited Wound Edges Assessment |
|
| SRS-C1R | Serous Exudate Assessment |
|
| SRS-D7N | Purulent Exudate Assessment |
|
| SRS-D9T | Maceration Surface Quantification |
|
| SRS-E4R | Erythema Intensity Quantification |
|
| SRS-Y6F | Crusting Intensity Quantification |
|
| SRS-F2K | Thickened Wound Edges Assessment |
|
| SRS-T3K | Induration Intensity Quantification |
|
| SRS-F6J | Hair Loss Surface Quantification |
|
| SRS-G3P | Wound Perilesional Erythema Assessment |
|
| SRS-G9R | Wound Stage Classification |
|
| SRS-H5K | Erythema Surface Quantification |
|
| SRS-H9X | Lichenification Intensity Quantification |
|
| SRS-I7T | Wound Affected Tissue - Intact Skin |
|
| SRS-J5P | Hair Follicle Quantification |
|
| SRS-J9V | Indistinguishable Wound Edges Assessment |
|
| SRS-K3H | Wound Affected Tissue - Subcutaneous |
|
| SRS-K4U | Orthopedic Material Surface Quantification |
|
| SRS-L4W | Damaged Wound Edges Assessment |
|
| SRS-L8Y | Biofilm and Slough Surface Quantification |
|
| SRS-M2L | Xerosis Intensity Quantification |
|
| SRS-M6P | Granulation Tissue Surface Quantification |
|
| SRS-N2C | Bone Surface Segmentation |
|
| SRS-N5Q | Swelling Intensity Quantification |
|
| SRS-N8W | Wound Affected Tissue - Dermis-Epidermis |
|
| SRS-O5M | Wound Affected Tissue - Muscle |
|
| SRS-L3X | Skin Surface Segmentation |
|
| SRS-Z5N | Hive Lesion Quantification |
|
| SRS-Z8P | Biofilm-Compatible Tissue Assessment |
|
| SRS-P4X | Wound Bed Tissue - Slough |
|
| SRS-P9W | Desquamation Intensity Quantification |
|
| SRS-Q1L | Hypopigmentation or Depigmentation Surface Quantification |
|
| SRS-Q8Z | Diffuse Wound Edges Assessment |
|
| SRS-R3W | Wound Bed Surface Quantification |
|
| SRS-R7C | Oozing Intensity Quantification |
|
| SRS-S2V | Wound Affected Tissue - Bone |
|
| SRS-S8M | Acneiform Lesion Type Quantification |
|
| SRS-T6H | Wound AWOSI Score Quantification |
|
| SRS-T9U | Wound Bed Tissue - Closed |
|
| SRS-U4M | Perilesional Maceration Assessment |
|
| SRS-U8Z | Nail Lesion Surface Quantification |
|
| SRS-V1D | Excoriation Intensity Quantification |
|
| SRS-V7Q | Necrosis Surface Quantification |
|
| SRS-W3R | Hyperpigmentation Surface Quantification |
|
| SRS-W9K | Bloody Exudate Assessment |
|
| SRS-X5B | Fibrinous Exudate Assessment |
|
| SRS-X8Q | Follicular and Inflammatory Pattern Identification |
|
| SRS-Y2E | Wound Bed Tissue - Granulation |
|
| SRS-W6T | Orchestrate Clinical Signs Analysis Workflow |
|
| SRS-H2V | Head Detection |
|
| SRS-E1V | Body Surface Segmentation |
|
| SRS-9ZT | The product classifies the image's modality |
|
| SRS-O93 | The product checks the image's clinical domain |
|
| SRS-Y5W | The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm |
|
Part 3: Software Requirements (SRS) to Test Cases
| SRS Id | SRS Name | Commit SHA | Test Case Id | Test Case Title | Reviewer | Review Status | Test Case URL | Test Id | Test URL | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| SRS-7PJ | Network Service Exposure | 3e665d001836b7047732f81944bc46a1b78d4491 | C50 | Verify the API service accepts incoming HTTP requests on the designated network port | Gerardo Fernández | Approved | View | T105 | View | ✅ |
| SRS-AQM | Standard HTTP Status Code Usage | 5437d177ca46efc0a2aee07795a01f277e7d6309 | C62 | Verify API returns 200 HTTP status codes for successful requests | Gerardo Fernández | Approved | View | T106 | View | ✅ |
| SRS-BYJ | JSON Data Interchange Format | 5437d177ca46efc0a2aee07795a01f277e7d6309 | C68 | Verify API processes JSON requests and returns JSON responses with correct Content-Type headers | Gerardo Fernández | Approved | View | T107 | View | ✅ |
| SRS-DW0 | User Authentication Endpoint Implementation | 9457a72ec5a38e1da7230ded0eab6009653e2d02 | C77 | Verify successful user authentication and token generation via the POST /auth/login endpoint | Gerardo Fernández | Approved | View | T109 | View | ✅ |
| SRS-D3N | Provision of Clinical Parameter Endpoints | 175ceb47259bb94067a1b32781d296431f3de0d2 | C73 | Verify retrieval and filtering of clinical signs data via /clinical/severity-experts endpoint | Gerardo Fernández | Approved | View | T108 | View | ✅ |
| SRS-LBS | URL-Based API Versioning | c0e67a0f3c8791c893d82e34e250822316f1a1b6 | C106 | Verify API endpoints are accessible via URL paths prefixed with the major and minor version identifier | Gerardo Fernández | Approved | View | T110 | View | ✅ |
| SRS-MZC | Request Body Size Limitation | 45df8326922e46467821cd50f5ed256c1fc91265 | C110 | Verify the API returns HTTP 413 when the request body exceeds the configured maximum size | Gerardo Fernández | Approved | View | T111 | View | ✅ |
| SRS-Q9M | Clinical Signs Analysis Endpoint Implementation | 83628274c21ab0a9f5b8708a5ba260e704cf1f04 | C124 | Verify POST /clinical/severity-assessment returns quantified results for valid image and sign list | Gerardo Fernández | Approved | View | T112 | View | ✅ |
| SRS-RXK | Diagnostic Support Endpoint Implementation | e0acb00226584d123dbf076320fa5c982bae3de4 | C128 | Verify the diagnosis-support endpoint accepts valid images and returns diagnostic analysis | Gerardo Fernández | Approved | View | T113 | View | ✅ |
| SRS-ZQO | Concurrent API Version Support | c0e67a0f3c8791c893d82e34e250822316f1a1b6 | C162 | Verify simultaneous availability and processing of requests across distinct API versions | Gerardo Fernández | Approved | View | T114 | View | |
| SRS-ID7 | Input Data Validation | 9ddd7569150f49e8a8e7bf7dea474fd0151d969f | C330 | Verify API rejects malformed inputs with standardized 422 Unprocessable Entity responses | Gerardo Fernández | Approved | View | T115 | View | ✅ |
| SRS-EH4 | Security-Safe Error Handling | e73a2e5b9fb16994ed8863928fc1170d27c89ec2 | C331 | Verify API returns sanitized error responses with appropriate HTTP status codes and no internal details | Gerardo Fernández | Approved | View | T116 | View | ✅ |
| SRS-AQM | Standard HTTP Status Code Usage | 5437d177ca46efc0a2aee07795a01f277e7d6309 | C454 | Verify API returns 401 HTTP status codes for wrong login requests | Gerardo Fernández | Approved | View | T272 | View | ✅ |
| SRS-AQM | Standard HTTP Status Code Usage | 5437d177ca46efc0a2aee07795a01f277e7d6309 | C455 | Verify API returns 422 HTTP status code when invalid data is submitted | Gerardo Fernández | Approved | View | T273 | View | ✅ |
| SRS-GER | System Behavior on Internal Component Failure. | 1a0ccc9ff2e12bfabbb7416413594855054492a3 | C456 | Verification of controlled 503 response and graceful degradation during downstream service failure. | Gerardo Fernández | Approved | View | T300 | View | ✅ |
| SRS-6KE | API Health Check Endpoint | 67fcd201c0c34f02bf9a7f296f5d30b48a449bdf | C169 | Verify health check endpoint returns unhealthy when some service is unavailable | Gerardo Fernández | Approved | View | T121 | View | ✅ |
| SRS-6KE | API Health Check Endpoint | 67fcd201c0c34f02bf9a7f296f5d30b48a449bdf | C46 | Verify the public health endpoint returns HTTP 200 and status OK when operational | Gerardo Fernández | Approved | View | T118 | View | ✅ |
| SRS-BA6 | Display the legal information about this medical device | be09165d77882d22cd597701fc7208e781c4b4fd | C66 | Verify retrieval of mandatory legal information, UDI, and regulatory metadata via API | Gerardo Fernández | Approved | View | T119 | View | ✅ |
| SRS-Z24 | API Documentation Endpoint | c5299af33cd65649bc9ac05042ddc2af2f27ec46 | C159 | Verify availability of OpenAPI specification and interactive documentation endpoints | Gerardo Fernández | Approved | View | T120 | View | ✅ |
| SRS-Q3Q | Generate an aggregated ICD probability distribution from a set of images | ce07d6bc71d9381b29143f6991553e397e2af717 | C255 | Verify API returns aggregated ICD probability distribution with structured code details in studyAggregate array | Gerardo Fernández | Approved | View | T122 | View | ✅ |
| SRS-0AB | Generate per-image ICD analysis with explainability heat map | bb4ee4ec42e52cc235bcbdd8b8521075e1522883 | C256 | Verify response includes per-image ICD probabilities and heat maps for the top five categories | Gerardo Fernández | Approved | View | T123 | View | ✅ |
| SRS-58W | Include entropy score in report | 66516edac9d596a17b83405b07e4b49a5ab9d25a | C258 | Verify response includes normalized entropy score between 0 and 1 in findings | Gerardo Fernández | Approved | View | T125 | View | ✅ |
| SRS-71I | Include the indicator of needing a high priority referral in the report | 12c87e3ebe43cb2888704a822e151ed65ae08d03 | C260 | Verify report response includes highPriorityReferral score within riskMetrics object | Gerardo Fernández | Approved | View | T127 | View | ✅ |
| SRS-8HY | Include the indicator of malignancy in the report | 7a23b8e8e140bfc891a5a336b57503df3290c076 | C261 | Verify report response includes malignantConditionProbability score within riskMetrics object | Gerardo Fernández | Approved | View | T128 | View | ✅ |
| SRS-D08 | Include the indicator of the image presenting a pigmented lesion in the report | 7a23b8e8e140bfc891a5a336b57503df3290c076 | C262 | Verify report response includes pigmentedLesion score within riskMetrics object | Gerardo Fernández | Approved | View | T129 | View | ✅ |
| SRS-JLM | Include the indicator of the presence of a condition in the report | e1ff30861d0ca1d17a688780ffdc8416b08af50e | C263 | Verify report response includes anyConditionProbability score within riskMetrics object | Gerardo Fernández | Approved | View | T130 | View | ✅ |
| SRS-KAS | Include the indicator of needing an urgent referral in the report | 12c87e3ebe43cb2888704a822e151ed65ae08d03 | C264 | Verify report response includes urgentReferral score within riskMetrics object | Gerardo Fernández | Approved | View | T131 | View | ✅ |
| SRS-K7M | Orchestrate diagnosis support workflow | ccd236d6da920ea8518d49352917abde3a07e380 | C265 | Verify diagnosis workflow returns ranked ICD-11 codes, binary indicators, and explainability maps for valid images | Gerardo Fernández | Approved | View | T132 | View | ✅ |
| SRS-A9F | Wound Bed Tissue - Epithelial | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C266 | Verify epithelial tissue classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T133 | View | ✅ |
| SRS-B3Z | Inflammatory Pattern Identification | 13d2f3fee665834cab27bf4c7775d70fc032e79f | C267 | Verify API returns Hurley stage and inflammatory status with associated probabilities for valid image input | Gerardo Fernández | Approved | View | T134 | View | ✅ |
| SRS-B6L | Wound Bed Tissue - Necrotic | 69f87eca8bd38d25b519b7b3ae45a8b57ef87d37 | C268 | Verify tissue wound bed necrotic classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T135 | View | ✅ |
| SRS-B8N | Pustule Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C269 | Verify pustule classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T136 | View | ✅ |
| SRS-A4W | Inflammatory Nodular Lesion Quantification | 9aa3c03db45e210c2e0ebf416de2b4313876d0dd | C270 | Verify inflammatory nodular lesion detector return correct counts and bounding boxes for drainning tunnels | Gerardo Fernández | Approved | View | T137 | View | ✅ |
| SRS-A6T | Delimited Wound Edges Assessment | 0b81afcee7dfbb8aa6c62ad3642235d545c017f9 | C271 | Verify wound borders delimited classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T138 | View | ✅ |
| SRS-C1R | Serous Exudate Assessment | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C272 | Verify wound exudation serous classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T139 | View | ✅ |
| SRS-D7N | Purulent Exudate Assessment | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C274 | Verify wound exudation purulent classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T141 | View | ✅ |
| SRS-D9T | Maceration Surface Quantification | cd6d5708a7544686f7423a834ed3aa128f84cf1f | C275 | Verify wound maceration segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T142 | View | ✅ |
| SRS-E4R | Erythema Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C276 | Verify erythema classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T143 | View | ✅ |
| SRS-Y6F | Crusting Intensity Quantification | fafd6724110f48c2a14b22d8899654fec857e6cf | C277 | Verify crusting classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T144 | View | ✅ |
| SRS-F2K | Thickened Wound Edges Assessment | 0b81afcee7dfbb8aa6c62ad3642235d545c017f9 | C278 | Verify thickened wound borders classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T145 | View | ✅ |
| SRS-T3K | Induration Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C279 | Verify induration classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T146 | View | ✅ |
| SRS-F6J | Hair Loss Surface Quantification | 80aca9ea492b4a00d38fb9475f641d95ca7538f9 | C280 | Verify hair loss segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T147 | View | ✅ |
| SRS-G3P | Wound Perilesional Erythema Assessment | 524ed8f71f74ccb494929fd9fd2d79649e755d99 | C281 | Verify wound perilesional erythema classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T148 | View | ✅ |
| SRS-G9R | Wound Stage Classification | 1c08ac0744595495e59baf99844d92ca240e36af | C282 | Verify wound stage classification returns right score and confidence metrics from a valid wound image | Gerardo Fernández | Approved | View | T149 | View | ✅ |
| SRS-H5K | Erythema Surface Quantification | 524ed8f71f74ccb494929fd9fd2d79649e755d99 | C283 | Verify erythema segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T150 | View | ✅ |
| SRS-H9X | Lichenification Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C284 | Verify lichenification classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T151 | View | ✅ |
| SRS-I7T | Wound Affected Tissue - Intact Skin | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C285 | Verify wound affected tissues intact classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T152 | View | ✅ |
| SRS-J5P | Hair Follicle Quantification | 3da6d2f72803c32efa59bd6330f16e472e1dffb5 | C286 | Verify API returns follicle count, bounding boxes, and confidence scores for a valid scalp image | Gerardo Fernández | Approved | View | T153 | View | ✅ |
| SRS-J9V | Indistinguishable Wound Edges Assessment | 0b81afcee7dfbb8aa6c62ad3642235d545c017f9 | C287 | Verify wound borders indistinguishable classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T154 | View | ✅ |
| SRS-K3H | Wound Affected Tissue - Subcutaneous | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C288 | Verify wound affected tissues subcutaneous classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T155 | View | ✅ |
| SRS-K4U | Orthopedic Material Surface Quantification | ac4cc1b8609bc67fb67de904cae2305a35000eb3 | C289 | Verify wound orthopedic material segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T156 | View | ✅ |
| SRS-L4W | Damaged Wound Edges Assessment | 0b81afcee7dfbb8aa6c62ad3642235d545c017f9 | C290 | Verify wound borders damaged classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T157 | View | ✅ |
| SRS-L8Y | Biofilm and Slough Surface Quantification | 6b479d5371886e425abf08bd1fa0fe9db1851b27 | C291 | Verify wound biofilm material segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T158 | View | ✅ |
| SRS-M2L | Xerosis Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C292 | Verify xerosis classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T159 | View | ✅ |
| SRS-M6P | Granulation Tissue Surface Quantification | 4b3ed220fbc0dac3ac8ba4ed25dc854824596a8d | C293 | Verify wound granulation segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T160 | View | ✅ |
| SRS-N2C | Bone Surface Segmentation | 21985a46323f455af83abb1de509450461fb8945 | C294 | Verify wound bone segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T161 | View | ✅ |
| SRS-N5Q | Swelling Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C295 | Verify swelling classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T162 | View | ✅ |
| SRS-N8W | Wound Affected Tissue - Dermis-Epidermis | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C296 | Verify wound exudation serous classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T163 | View | ✅ |
| SRS-O5M | Wound Affected Tissue - Muscle | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C297 | Verify wound affected tissues muscle classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T164 | View | ✅ |
| SRS-L3X | Skin Surface Segmentation | 6402f7f36831b49314b9b1602e4a928cfc6c771e | C298 | Verify skin segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T165 | View | ✅ |
| SRS-Z5N | Hive Lesion Quantification | b43e1688a3b7bd57bebe34920cbdf4382ac5a463 | C299 | Verify hive detector return correct counts and bounding boxes for hives | Gerardo Fernández | Approved | View | T166 | View | ✅ |
| SRS-Z8P | Biofilm-Compatible Tissue Assessment | 6b479d5371886e425abf08bd1fa0fe9db1851b27 | C300 | Verify wound biofilm tissue classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T167 | View | ✅ |
| SRS-P4X | Wound Bed Tissue - Slough | 6b479d5371886e425abf08bd1fa0fe9db1851b27 | C302 | Verify tissue wound bed slough classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T169 | View | ✅ |
| SRS-P9W | Desquamation Intensity Quantification | 7b50a8f3820cd7e662dcfc14c8c6d003f9c704a9 | C303 | Verify desquamation classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T170 | View | ✅ |
| SRS-Q1L | Hypopigmentation or Depigmentation Surface Quantification | 9a0390133a15a446f1eef9a4aeda874fdd747902 | C304 | Verify hypopigmentation segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T171 | View | ✅ |
| SRS-Q8Z | Diffuse Wound Edges Assessment | 0b81afcee7dfbb8aa6c62ad3642235d545c017f9 | C305 | Verify wound borders diffused classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T172 | View | ✅ |
| SRS-R3W | Wound Bed Surface Quantification | 98cf89c1cea8c7a15217017e778fdb2aebfe91cb | C306 | Verify wound bed segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T173 | View | ✅ |
| SRS-R7C | Oozing Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C307 | Verify oozing classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T174 | View | ✅ |
| SRS-S2V | Wound Affected Tissue - Bone | 21985a46323f455af83abb1de509450461fb8945 | C308 | Verify wound affected tissues bone classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T175 | View | ✅ |
| SRS-S8M | Acneiform Lesion Type Quantification | e8e6d9d811a14cfb28c0280ad89ad897b3195237 | C309 | Verify acneiform detector return correct counts and bounding boxes for papules, pustules, spots | Gerardo Fernández | Approved | View | T176 | View | ✅ |
| SRS-T6H | Wound AWOSI Score Quantification | 1c08ac0744595495e59baf99844d92ca240e36af | C310 | Verify AWOSI classification returns right score and confidence metrics from a valid wound image | Gerardo Fernández | Approved | View | T177 | View | ✅ |
| SRS-T9U | Wound Bed Tissue - Closed | 3cc2af57186b3e2d6e104bbd4d0fa453bb933a05 | C311 | Verify tissue wound bed closed classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T178 | View | ✅ |
| SRS-U4M | Perilesional Maceration Assessment | cd6d5708a7544686f7423a834ed3aa128f84cf1f | C312 | Verify wound perilesional maceration classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T179 | View | ✅ |
| SRS-U8Z | Nail Lesion Surface Quantification | c9bff523adf85be5af207f9249ef5f0d69d47a12 | C313 | Verify nail lesion segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T180 | View | ✅ |
| SRS-V1D | Excoriation Intensity Quantification | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C314 | Verify excoriation classification returns right intensity and confidence | Gerardo Fernández | Approved | View | T181 | View | ✅ |
| SRS-V7Q | Necrosis Surface Quantification | 69f87eca8bd38d25b519b7b3ae45a8b57ef87d37 | C315 | Verify wound necrosis segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T182 | View | ✅ |
| SRS-W3R | Hyperpigmentation Surface Quantification | 492182224cc07eb6b28363eeda7d44d7650a6c9d | C316 | Verify hyperpigmentation segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T183 | View | ✅ |
| SRS-W9K | Bloody Exudate Assessment | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C317 | Verify wound bloody exudation classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T184 | View | ✅ |
| SRS-X5B | Fibrinous Exudate Assessment | 8a90efa14fb67f3f8ae28a1561537d8b46f13f1f | C318 | Verify wound exudation fibrinous classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T185 | View | ✅ |
| SRS-X8Q | Follicular and Inflammatory Pattern Identification | 3da6d2f72803c32efa59bd6330f16e472e1dffb5 | C319 | Verify follicular and inflammatory pattern identification returns right result | Gerardo Fernández | Approved | View | T186 | View | ✅ |
| SRS-Y2E | Wound Bed Tissue - Granulation | 4b3ed220fbc0dac3ac8ba4ed25dc854824596a8d | C320 | Verify wound tissue wound bed granulation classification returns right presence prediction and confidence score | Gerardo Fernández | Approved | View | T187 | View | ✅ |
| SRS-W6T | Orchestrate Clinical Signs Analysis Workflow | ccd236d6da920ea8518d49352917abde3a07e380 | C321 | Verify generation of structured clinical assessment report with quantified results for requested signs via API | Gerardo Fernández | Approved | View | T188 | View | ✅ |
| SRS-E1V | Body Surface Segmentation | 3089eb6b2b1f76b9df0498e37cf2b05ac05cbeb6 | C325 | Verify body surface segmentation analysis returns segmentation masks and the right percentage of surface affected | Gerardo Fernández | Approved | View | T193 | View | ✅ |
| SRS-S8M | Acneiform Lesion Type Quantification | e8e6d9d811a14cfb28c0280ad89ad897b3195237 | C446 | Verify acneiform detector return correct counts and bounding boxes for nodules, pustules and scabs | Gerardo Fernández | Approved | View | T264 | View | ✅ |
| SRS-S8M | Acneiform Lesion Type Quantification | e8e6d9d811a14cfb28c0280ad89ad897b3195237 | C447 | Verify acneiform detector return correct counts and bounding boxes for scabs, comedones, papules and pustules | Gerardo Fernández | Approved | View | T265 | View | ✅ |
| SRS-Z5N | Hive Lesion Quantification | b43e1688a3b7bd57bebe34920cbdf4382ac5a463 | C448 | Verify hive detector return correct counts and bounding boxes for hives (second image) | Gerardo Fernández | Approved | View | T266 | View | ✅ |
| SRS-A4W | Inflammatory Nodular Lesion Quantification | 9aa3c03db45e210c2e0ebf416de2b4313876d0dd | C449 | Verify inflammatory nodular lesion detector return correct counts and bounding boxes for non drainning tunnels | Gerardo Fernández | Approved | View | T267 | View | ✅ |
| SRS-A4W | Inflammatory Nodular Lesion Quantification | 9aa3c03db45e210c2e0ebf416de2b4313876d0dd | C450 | Verify inflammatory nodular lesion detector return correct counts and bounding boxes for nodules | Gerardo Fernández | Approved | View | T268 | View | ✅ |
| SRS-H2V | Head Detection | d696b2e9d092bfea4a77f88806660c119cbf7b88 | C323 | Verify head detection returns right bounding boxes and heads count inside an image | Gerardo Fernández | Approved | View | T191 | View | ✅ |
| SRS-9ZT | The product classifies the image's modality | 9316f7a8be2d571d85c8a0ddec7efba1cd488443 | C327 | Verify API returns ""clinical"" for image modality category when a skin image is provided | Gerardo Fernández | Approved | View | T195 | View | ✅ |
| SRS-O93 | The product checks the image's clinical domain | 9316f7a8be2d571d85c8a0ddec7efba1cd488443 | C328 | Verify API returns image domain category equals to ""dermatological"" and confidence score for a skin image | Gerardo Fernández | Approved | View | T196 | View | ✅ |
| SRS-Y5W | The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm | ea193ffa19a80d2322d0fbd7d22fe17ca1f45571 | C329 | Verify API returns dermatological image quality score, interpretation, and acquisition feedback | Gerardo Fernández | Approved | View | T197 | View | ✅ |
| SRS-9ZT | The product classifies the image's modality | 9316f7a8be2d571d85c8a0ddec7efba1cd488443 | C451 | Verify API returns ""dermoscopic"" for image modality category when a skin image is provided | Gerardo Fernández | Approved | View | T269 | View | ✅ |
| SRS-O93 | The product checks the image's clinical domain | 9316f7a8be2d571d85c8a0ddec7efba1cd488443 | C452 | Verify API returns image domain category equals to ""non_dermatological"" and confidence score for a dog image | Gerardo Fernández | Approved | View | T270 | View | ✅ |
| SRS-F05 | Generate FHIR DiagnosticReport Base Structure | 866081f8469c001d52f6d7ca4493dbd2b820f9f4 | C453 | Verify FHIR DiagnosticReport base structure for a segmenter | Gerardo Fernández | Approved | View | T271 | View | ✅ |
| SRS-1KW | Secure Communication Protocol Enforcement | 45df8326922e46467821cd50f5ed256c1fc91265 | C332 | Verify API accepts requests over HTTPS using TLS 1.2 or 1.3 | Gerardo Fernández | Approved | View | T198 | View | ✅ |
| SRS-1KW | Secure Communication Protocol Enforcement | 45df8326922e46467821cd50f5ed256c1fc91265 | C333 | Verify API rejects or redirects unencrypted HTTP requests | Gerardo Fernández | Approved | View | T199 | View | ✅ |
| SRS-28X | Implement progressive delays between failed login attempts | ae97659c200e930e6d482ada87d85320eb6b980d | C335 | Verify progressive increase in enforced delay across consecutive failed authentication attempts | Gerardo Fernández | Approved | View | T201 | View | ✅ |
| SRS-28X | Implement progressive delays between failed login attempts | ae97659c200e930e6d482ada87d85320eb6b980d | C336 | Verify delay resets upon successful authentication | Gerardo Fernández | Approved | View | T202 | View | ✅ |
| SRS-A25 | Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions | 56792dc7766f00e6c3cd7f07da45da4808739d82 | C337 | Verify successful access to permitted endpoints for an authorized role | Gerardo Fernández | Approved | View | T203 | View | ✅ |
| SRS-A25 | Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions | 56792dc7766f00e6c3cd7f07da45da4808739d82 | C338 | Verify access denial for endpoints outside the assigned role scope | Gerardo Fernández | Approved | View | T204 | View | ✅ |
| SRS-A2B | API Rate Limiting | 05a6336f79c149468746b6b212d597b7d5c1eb76 | C339 | Verify HTTP 403 response when request volume exceeds defined threshold | Gerardo Fernández | Approved | View | T205 | View | ✅ |
| SRS-A2B | API Rate Limiting | 05a6336f79c149468746b6b212d597b7d5c1eb76 | C340 | Verify request acceptance after rate limit time window expiration | Gerardo Fernández | Approved | View | T206 | View | ✅ |
| SRS-MM8 | Generated JWTs must have an expiration date | 0fb498ac02a4da9cf0c06e2311082a8876ad246e | C341 | Verify generated authentication tokens include the expiration claim | Gerardo Fernández | Approved | View | T207 | View | ✅ |
| SRS-MM8 | Generated JWTs must have an expiration date | 0fb498ac02a4da9cf0c06e2311082a8876ad246e | C342 | Verify access denial for requests using an expired JWT | Gerardo Fernández | Approved | View | T208 | View | ✅ |
| SRS-SDZ | Use hashed and salted passwords | dfbc23d18a8ad4e1026b749c2357e213aa2935ae | C343 | Verify generation of authentication token using valid credentials | Gerardo Fernández | Approved | View | T209 | View | ✅ |
| SRS-SDZ | Use hashed and salted passwords | dfbc23d18a8ad4e1026b749c2357e213aa2935ae | C344 | Verify rejection of authentication requests with invalid credentials | Gerardo Fernández | Approved | View | T210 | View | ✅ |
| SRS-SDZ | Use hashed and salted passwords | dfbc23d18a8ad4e1026b749c2357e213aa2935ae | C345 | Verify password update functionality and subsequent authentication | Gerardo Fernández | Approved | View | T211 | View | ✅ |
| SRS-TPK | Lock accounts after five failed attempts | b60cff1087fe074f380a201655ba882b3ca9d32b | C346 | Verify account lockout enforcement after threshold reached | Gerardo Fernández | Approved | View | T212 | View | ✅ |
| SRS-TPK | Lock accounts after five failed attempts | b60cff1087fe074f380a201655ba882b3ca9d32b | C347 | Verify failed attempt counter reset on successful login | Gerardo Fernández | Approved | View | T213 | View | ✅ |
| SRS-TPK | Lock accounts after five failed attempts | b60cff1087fe074f380a201655ba882b3ca9d32b | C348 | Verify administrative manual account unlock capability | Gerardo Fernández | Approved | View | T214 | View | ✅ |
| SRS-U8M | Enforce strong password policies (min. 12 characters, complexity rules, expiration policies) | f620de037a1e1c3b92d9ececc17b6f15cba83b4f | C349 | Verify enforcement of password complexity and length constraints | Gerardo Fernández | Approved | View | T215 | View | ✅ |
| SRS-U8M | Enforce strong password policies (min. 12 characters, complexity rules, expiration policies) | f620de037a1e1c3b92d9ececc17b6f15cba83b4f | C350 | Verify authentication behavior for expired passwords | Gerardo Fernández | Approved | View | T216 | View | ✅ |
| SRS-WER | Endpoint Access Control | c5299af33cd65649bc9ac05042ddc2af2f27ec46 | C351 | Verify protected endpoints allow access with a valid OAuth 2.0 Bearer token | Gerardo Fernández | Approved | View | T217 | View | ✅ |
| SRS-WER | Endpoint Access Control | c5299af33cd65649bc9ac05042ddc2af2f27ec46 | C352 | Verify protected endpoints reject requests lacking a valid token with 401 Unauthorized | Gerardo Fernández | Approved | View | T218 | View | ✅ |
| SRS-WER | Endpoint Access Control | c5299af33cd65649bc9ac05042ddc2af2f27ec46 | C353 | Verify public endpoints are accessible without an Authorization header | Gerardo Fernández | Approved | View | T219 | View | ✅ |
| SRS-WGF | AES-256 encryption for data at rest | d053992d42d60f71a88a28d3e56ea6da46294a5f | C354 | Verify AES-256 encryption configuration for data storage | Gerardo Fernández | Approved | View | T220 | View | ✅ |
| SRS-X9J | Conduct periodic access reviews to verify permissions align with job functions | f620de037a1e1c3b92d9ececc17b6f15cba83b4f | C355 | Verify authorized administrator can retrieve current user information for review | Gerardo Fernández | Approved | View | T221 | View | ✅ |
| SRS-X9J | Conduct periodic access reviews to verify permissions align with job functions | f620de037a1e1c3b92d9ececc17b6f15cba83b4f | C356 | Verify authorized administrator can revoke permissions during access review | Gerardo Fernández | Approved | View | T222 | View | ✅ |
| SRS-IC4 | Software and Configuration Integrity Verification | dc4180b5afa19d3b2bac9c1805f1b65eed2ab8bb | C357 | Verify successful execution and audit logging of system integrity checks | Gerardo Fernández | Approved | View | T223 | View | ✅ |
| SRS-BK7 | Encrypted Backup and Integrity Verification | d053992d42d60f71a88a28d3e56ea6da46294a5f | C363 | Verify backup generation | Gerardo Fernández | Approved | View | T225 | View | ✅ |
| SRS-BK7 | Encrypted Backup and Integrity Verification | d053992d42d60f71a88a28d3e56ea6da46294a5f | C364 | Verify automated backup generation | Gerardo Fernández | Approved | View | T226 | View | ✅ |
| SRS-CCD | Intrusion Prevention and Malicious Traffic Detection | 45df8326922e46467821cd50f5ed256c1fc91265 | C366 | Verify blocking of anomalous high-frequency request bursts | Gerardo Fernández | Approved | View | T228 | View | ✅ |
| SRS-F05 | Generate FHIR DiagnosticReport Base Structure | 866081f8469c001d52f6d7ca4493dbd2b820f9f4 | C368 | Verify FHIR DiagnosticReport base structure for a detector | Gerardo Fernández | Approved | View | T230 | View | ✅ |
| SRS-FMG | Record Analysis Duration in Report | ef4c4f23bc67f3e0ab17075c219294dc8ff39fa1 | C369 | Verify analysisDuration field population in DiagnosticReport | Gerardo Fernández | Approved | View | T231 | View | ✅ |
| SRS-JC6 | The product provides a final image validity summary | ea193ffa19a80d2322d0fbd7d22fe17ca1f45571 | C370 | Verify isAssessable is true when domain and quality criteria are met | Gerardo Fernández | Approved | View | T232 | View | ✅ |
| SRS-JC6 | The product provides a final image validity summary | ea193ffa19a80d2322d0fbd7d22fe17ca1f45571 | C371 | Verify isAssessable is false when image quality is unacceptable | Gerardo Fernández | Approved | View | T233 | View | ✅ |
| SRS-JC6 | The product provides a final image validity summary | ea193ffa19a80d2322d0fbd7d22fe17ca1f45571 | C372 | Verify isAssessable is false when image is non-dermatological | Gerardo Fernández | Approved | View | T234 | View | ✅ |
| SRS-K6N | Map Per-Image Analysis to a dedicated object in the report | c7651f8d92ca3b2231bf87c202edb67903ca164a | C373 | Verify single image analysis maps to structured object in imageAnalyses array | Gerardo Fernández | Approved | View | T235 | View | ✅ |
| SRS-K6N | Map Per-Image Analysis to a dedicated object in the report | c7651f8d92ca3b2231bf87c202edb67903ca164a | C374 | Verify multiple image analyses map to distinct objects in imagingAnalysis array | Gerardo Fernández | Approved | View | T236 | View | ✅ |
| SRS-H3J | Deterministic Response Schemas | 9ddd7569150f49e8a8e7bf7dea474fd0151d969f | C375 | Verify response structure compliance with OpenAPI success schema | Gerardo Fernández | Approved | View | T237 | View | ✅ |
| SRS-H3J | Deterministic Response Schemas | 9ddd7569150f49e8a8e7bf7dea474fd0151d969f | C376 | Verify response structure compliance with OpenAPI error schema | Gerardo Fernández | Approved | View | T238 | View | ✅ |
| SRS-W5Z | Assign DiagnosticReport Identifier | 7c98fffc302ad65ccecb6237d6579ea5dc9c6d04 | C377 | Verify Assignment of Official Identifier to DiagnosticReport | Gerardo Fernández | Approved | View | T239 | View | ✅ |
| SRS-W5Z | Assign DiagnosticReport Identifier | 7c98fffc302ad65ccecb6237d6579ea5dc9c6d04 | C378 | Verify Uniqueness of Generated DiagnosticReport Identifiers | Gerardo Fernández | Approved | View | T240 | View | ✅ |
| SRS-D6W | Accurate Time Synchronization | 107088729759f59e8b256bc374b3553b28c4ac47 | C382 | Verify System Timestamp Accuracy via API Response Headers | Gerardo Fernández | Approved | View | T244 | View | ✅ |
| SRS-D6W | Accurate Time Synchronization | 107088729759f59e8b256bc374b3553b28c4ac47 | C383 | Verify System Time Synchronization and Accuracy Status | Gerardo Fernández | Approved | View | T245 | View | ✅ |
| SRS-SI2 | Secure Audit Trail Access Interface | d053992d42d60f71a88a28d3e56ea6da46294a5f | C388 | Verify Role-Based Access Control for Audit Trail Interface | Gerardo Fernández | Approved | View | T247 | View | ✅ |
| SRS-SI2 | Secure Audit Trail Access Interface | d053992d42d60f71a88a28d3e56ea6da46294a5f | C389 | Verify Audit Trail Search and Export Capabilities | Gerardo Fernández | Approved | View | T248 | View | ✅ |
| SRS-T5P | Audit Record Integrity Protection | d053992d42d60f71a88a28d3e56ea6da46294a5f | C391 | Verify audit records cannot be modified or deleted via API | Gerardo Fernández | Approved | View | T249 | View | ✅ |
| SRS-PU2 | Comprehensive Event Auditing | d053992d42d60f71a88a28d3e56ea6da46294a5f | C395 | Verify audit trail generation for authentication lifecycle and security anomalies | Gerardo Fernández | Approved | View | T251 | View | ✅ |
| SRS-U2P | Consolidated Audit Record Content | ccce090b3840da989088cd689cfa68e49ace8825 | C398 | Verify audit record completeness for successful API event | Gerardo Fernández | Approved | View | T252 | View | ✅ |
| SRS-U2P | Consolidated Audit Record Content | ccce090b3840da989088cd689cfa68e49ace8825 | C399 | Verify audit record completeness for failed API event | Gerardo Fernández | Approved | View | T253 | View | ✅ |
| SRS-PU2 | Comprehensive Event Auditing | d053992d42d60f71a88a28d3e56ea6da46294a5f | C410 | Verify audit trail generation for clinical data creation events | Gerardo Fernández | Approved | View | T255 | View | ✅ |
| SRS-T95 | Audit System Failure Handling | 1a0ccc9ff2e12bfabbb7416413594855054492a3 | C413 | Audit record preservation during database unavailability | Gerardo Fernández | Approved | View | T258 | View | ✅ |
| SRS-BWB | Performance and Latency | ef4c4f23bc67f3e0ab17075c219294dc8ff39fa1 | C416 | Verify p95 API latency remains under 10 seconds during nominal load | Gerardo Fernández | Approved | View | T261 | View | ✅ |
Coverage Analysis
Risk Coverage
To be filled
- Total Risks Identified: 8
- Risks with SRS Mitigation: 8 (100%)
- Risks with Test Coverage: 8 (100%)
Requirement Coverage
- Total Product Requirements: 18
- PRs with SRS Implementation: 18 (100%)
- Total Software Requirements: 122
- SRS with Test Cases: 122 (100%)
Test Coverage
To be filled
- Total Test Cases: 159
- Tests Passed (RC3): 50 (100%)
- Tests Failed (RC3): 0 (0%)
- Blocked Tests (RC3): 0 (0%)
Conclusion
This traceability matrix demonstrates complete coverage of:
- All identified risks are mitigated by software requirements
- All product requirements are implemented by software requirements
- All software requirements are verified by test cases
- All tests have been executed and passed in the final release candidate (RC3)
The traceability analysis confirms that Legit Health Plus v1.1.0.0 meets all requirements and has been adequately tested for release.
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