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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
      • R-TF-012-019 SOUPs
      • R-TF-012-030 Software Configuration Management Plan
      • Product Requirement Specification (PRS)
      • R-TF-012-033 Software Tests Plan
      • Software Requirement Specification (SRS)
        • SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
        • SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone
        • SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone
        • SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone
        • SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone
        • SRS-006: Generate ALADIN Score report for single zone
        • SRS-007: Generate Automatic VASI (AVASI) report for single zone
        • SRS-008: Generate Automatic AWOSI report for single zone
        • SRS-009: Generate Automatic NSIL report for single zone
        • SRS-010: Generate Automatic SALT (ASALT) report for single zone
        • SRS-011: Generate Automatic EASI (AEASI) report for single zone
        • SRS-012: Orchestrate severity analysis workflow
        • SRS-013 Generate an aggregated ICD probability distribution from an image
        • SRS-014 Generate per-image ICD analysis with explainability heat map
        • SRS-015 Generate an unified report of ICD class distributions
        • SRS-016: Include model sensitivity in report
        • SRS-017: Include model specificity in report
        • SRS-018: Include entropy score in report
        • SRS-019: Include the indicator of the presence of a condition in the report
        • SRS-020: Include the indicator of the image presenting a pigmented lesion in the report
        • SRS-021: Include the indicator of malignancy in the report
        • SRS-022: Include the indicator of needing an urgent referral in the report
        • SRS-023: Include the indicator of needing a high priority referral in the report
        • SRS-024 The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm
        • SRS-025 The product checks the image's clinical domain
        • SRS-026 The product classifies the image's modality
        • SRS-027 The product provides a final image validity summary
        • SRS-028: Orchestrate diagnosis support workflow
        • SRS-029: Compute 7-Point Checklist (7PC) Score
        • SRS-030: Compute Dermatology Life Quality Index (DLQI) Score
        • SRS-031: Compute PURE-4 Score
        • SRS-032: Compute Urticaria Control Test (UCT) Score
        • SRS-033: Calculate Global Acne Grading System (GAGS) Score
        • SRS-034: Calculate RESVECH Score
        • SRS-035: Calculate SCOVID Score
        • SRS-036: Calculate Physician's Global Assessment (PGA) Score
        • SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body
        • SRS-038: Secure Communication Protocol Enforcement
        • SRS-039: Network Service Exposure
        • SRS-040: URL-Based API Versioning
        • SRS-041: Concurrent API Version Support
        • SRS-042: JSON Data Interchange Format
        • SRS-044: Deterministic Response Schemas
        • SRS-045: Performance and Latency
        • SRS-046: Standard HTTP Status Code Usage
        • SRS-047: Endpoint Access Control
        • SRS-048: API Documentation Endpoint
        • SRS-049: High Availability and Load Balancing Support
        • SRS-051: API Rate Limiting
        • SRS-052: Request Body Size Limitation
        • SRS-053: Provision of Clinical Parameter Endpoints
        • SRS-054: API Health Check Endpoint
        • SRS-055: User Action Auditing
        • SRS-056: Authentication Event Auditing
        • SRS-057: Security Event Auditing
        • SRS-058: Consolidated Audit Record Content
        • SRS-059: Write-Once Audit Storage
        • SRS-060: Tamper-Evident Audit Records
        • SRS-061: Audit Tampering Detection and Logging
        • SRS-062: Secure Audit Trail Access Interface
        • SRS-063: Accurate Time Synchronization
        • SRS-064: Audit Trail Data Retention Policy
        • SRS-065: Audit System Failure Handling
        • SRS-066: System Information Endpoint Implementation
        • SRS-067: User Authentication Endpoint Implementation
        • SRS-068: Diagnostic Support Endpoint Implementation
        • SRS-069: Manual Severity Assessment Endpoint Implementation
        • SRS-070: Single-Zone Automatic Severity Assessment Endpoint Implementation
        • SRS-071: Full-Body Automatic Severity Assessment Endpoint Implementation
        • SRS-072: Device Information Endpoint Implementation
        • SRS-073: Generate FHIR DiagnosticReport Base Structure
        • SRS-074: Assign FHIR DiagnosticReport Identifier
        • SRS-075: Record Analysis Duration in FHIR Report
        • SRS-076: Encapsulate Proprietary Data
        • SRS-077: Map Aggregated Diagnostic Conclusions to FHIR
        • SRS-078: Embed Performance and Clinical Indicators in FHIR Report
        • SRS-079: Map Per-Image Analysis to FHIR
        • SRS-080: Embed Explainability Mechanisms in FHIR Report
        • SRS-081: Map Severity Assessment Scores to FHIR
        • SRS-082: Embed Detected Lesion Data in FHIR Report
        • SRS-083 Display the legal information about this medical device
        • SRS-084 Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions.
        • SRS-085 Conduct periodic access reviews to verify permissions align with job functions.
        • SRS-086 Enforce strong password policies (min. 12 characters, complexity rules, expiration policies).
        • SRS-087 Use hashed and salted passwords
        • SRS-088 Lock accounts after five failed attempts
        • SRS-089 Implement progressive delays between failed login attempts.
        • SRS-090 Generated JWTs must have an expiration date.
        • SRS-091 AES-256 encryption for data at rest
        • SRS-XXX: [Brief title of the software requirement]
      • R-TF-012-037 Labeling and IFU Requirements
      • R-TF-012-023 Software Development Plan
      • deprecated
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Design History File
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information
  • Software Requirement Specification (SRS)

Software Requirement Specification (SRS)

📄️ SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone

Identifier

📄️ SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone

Identifier

📄️ SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone

Identifier

📄️ SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone

Identifier

📄️ SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone

Identifier

📄️ SRS-006: Generate ALADIN Score report for single zone

Identifier

📄️ SRS-007: Generate Automatic VASI (AVASI) report for single zone

Identifier

📄️ SRS-008: Generate Automatic AWOSI report for single zone

Identifier

📄️ SRS-009: Generate Automatic NSIL report for single zone

Identifier

📄️ SRS-010: Generate Automatic SALT (ASALT) report for single zone

Identifier

📄️ SRS-011: Generate Automatic EASI (AEASI) report for single zone

Identifier

📄️ SRS-012: Orchestrate severity analysis workflow

Identifier

📄️ SRS-013 Generate an aggregated ICD probability distribution from an image

Identifier

📄️ SRS-014 Generate per-image ICD analysis with explainability heat map

Identifier

📄️ SRS-015 Generate an unified report of ICD class distributions

Identifier

📄️ SRS-016: Include model sensitivity in report

Identifier

📄️ SRS-017: Include model specificity in report

Identifier

📄️ SRS-018: Include entropy score in report

Identifier

📄️ SRS-019: Include the indicator of the presence of a condition in the report

Identifier

📄️ SRS-020: Include the indicator of the image presenting a pigmented lesion in the report

Identifier

📄️ SRS-021: Include the indicator of malignancy in the report

Identifier

📄️ SRS-022: Include the indicator of needing an urgent referral in the report

Identifier

📄️ SRS-023: Include the indicator of needing a high priority referral in the report

Identifier

📄️ SRS-024 The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm

Identifier

📄️ SRS-025 The product checks the image's clinical domain

Identifier

📄️ SRS-026 The product classifies the image's modality

Identifier

📄️ SRS-027 The product provides a final image validity summary

Identifier

📄️ SRS-028: Orchestrate diagnosis support workflow

Identifier

📄️ SRS-029: Compute 7-Point Checklist (7PC) Score

Identifier

📄️ SRS-030: Compute Dermatology Life Quality Index (DLQI) Score

Identifier

📄️ SRS-031: Compute PURE-4 Score

Identifier

📄️ SRS-032: Compute Urticaria Control Test (UCT) Score

Identifier

📄️ SRS-033: Calculate Global Acne Grading System (GAGS) Score

Identifier

📄️ SRS-034: Calculate RESVECH Score

Identifier

📄️ SRS-035: Calculate SCOVID Score

Identifier

📄️ SRS-036: Calculate Physician's Global Assessment (PGA) Score

Identifier

📄️ SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body

Identifier

📄️ SRS-038: Secure Communication Protocol Enforcement

Identifier

📄️ SRS-039: Network Service Exposure

Identifier

📄️ SRS-040: URL-Based API Versioning

Identifier

📄️ SRS-041: Concurrent API Version Support

Identifier

📄️ SRS-042: JSON Data Interchange Format

Identifier

📄️ SRS-044: Deterministic Response Schemas

Identifier

📄️ SRS-045: Performance and Latency

Identifier

📄️ SRS-046: Standard HTTP Status Code Usage

Identifier

📄️ SRS-047: Endpoint Access Control

Identifier

📄️ SRS-048: API Documentation Endpoint

Identifier

📄️ SRS-049: High Availability and Load Balancing Support

Identifier

📄️ SRS-051: API Rate Limiting

Identifier

📄️ SRS-052: Request Body Size Limitation

Identifier

📄️ SRS-053: Provision of Clinical Parameter Endpoints

Identifier

📄️ SRS-054: API Health Check Endpoint

Identifier

📄️ SRS-055: User Action Auditing

Identifier

📄️ SRS-056: Authentication Event Auditing

Identifier

📄️ SRS-057: Security Event Auditing

Identifier

📄️ SRS-058: Consolidated Audit Record Content

Identifier

📄️ SRS-059: Write-Once Audit Storage

Identifier

📄️ SRS-060: Tamper-Evident Audit Records

Identifier

📄️ SRS-061: Audit Tampering Detection and Logging

Identifier

📄️ SRS-062: Secure Audit Trail Access Interface

Identifier

📄️ SRS-063: Accurate Time Synchronization

Identifier

📄️ SRS-064: Audit Trail Data Retention Policy

Identifier

📄️ SRS-065: Audit System Failure Handling

Identifier

📄️ SRS-066: System Information Endpoint Implementation

Identifier

📄️ SRS-067: User Authentication Endpoint Implementation

Identifier

📄️ SRS-068: Diagnostic Support Endpoint Implementation

Identifier

📄️ SRS-069: Manual Severity Assessment Endpoint Implementation

Identifier

📄️ SRS-070: Single-Zone Automatic Severity Assessment Endpoint Implementation

Identifier

📄️ SRS-071: Full-Body Automatic Severity Assessment Endpoint Implementation

Identifier

📄️ SRS-072: Device Information Endpoint Implementation

Identifier

📄️ SRS-073: Generate FHIR DiagnosticReport Base Structure

Identifier

📄️ SRS-074: Assign FHIR DiagnosticReport Identifier

Identifier

📄️ SRS-075: Record Analysis Duration in FHIR Report

Identifier

📄️ SRS-076: Encapsulate Proprietary Data

Identifier

📄️ SRS-077: Map Aggregated Diagnostic Conclusions to FHIR

Identifier

📄️ SRS-078: Embed Performance and Clinical Indicators in FHIR Report

Identifier

📄️ SRS-079: Map Per-Image Analysis to FHIR

Identifier

📄️ SRS-080: Embed Explainability Mechanisms in FHIR Report

Identifier

📄️ SRS-081: Map Severity Assessment Scores to FHIR

Identifier

📄️ SRS-082: Embed Detected Lesion Data in FHIR Report

Identifier

📄️ SRS-083 Display the legal information about this medical device

Identifier

📄️ SRS-084 Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions.

Identifier

📄️ SRS-085 Conduct periodic access reviews to verify permissions align with job functions.

Identifier

📄️ SRS-086 Enforce strong password policies (min. 12 characters, complexity rules, expiration policies).

Identifier

📄️ SRS-087 Use hashed and salted passwords

Identifier

📄️ SRS-088 Lock accounts after five failed attempts

Identifier

📄️ SRS-089 Implement progressive delays between failed login attempts.

Identifier

📄️ SRS-090 Generated JWTs must have an expiration date.

Identifier

📄️ SRS-091 AES-256 encryption for data at rest

Identifier

📄️ SRS-XXX: [Brief title of the software requirement]

Identifier

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R-TF-012-033 Software Tests Plan
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SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)