Phase 3: Software Development Review (Release Candidate)

Process Overview

The purpose of the Software Development review (Phase 3) is to ensure that a Release Candidate is ready for verification testing. This review validates that coding, integration, and test planning have been completed, and that the software package meets the criteria to proceed to Phase 4 (Software Verification).

According to GP-012, Phase 3 follows agile and iterative development methodology, producing a Release Candidate with complete documentation and updated Design History File (DHF).

General Information

	Information
Device name	Legit.Health Plus (hereinafter, the device)
Model and type	NA
Version	1.1.0.0
Basic UDI-DI	8437025550LegitCADx6X
Certificate number (if available)	MDR 792790
EMDN code(s)	Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)
GMDN code	65975
EU MDR 2017/745	Class IIb
EU MDR Classification rule	Rule 11
Novel product (True/False)	TRUE
Novel related clinical procedure (True/False)	TRUE
SRN	ES-MF-000025345

Project Information

• Project title: Legit.Health Plus Version 1.1.0.0
• Project manager: JD-007 (Technical Manager)
• Review date: [Date to be completed]
• Reviewers: JD-001 (General Manager), JD-003 (Design & Development Manager), JD-007 (Technical Manager), JD-004 (Quality Manager & PRRC)

Planning

Phase	Object	Done
Phase 1 Product Design Review	Establish input data	✓
Phase 2 Software Design Review	SRs, Architectural Design and UI Prototypes	✓
Phase 3 Software Development	Coding, integration and test plan	✓
Phase 4 Software Verification Review	Software version verified and residual anomalies
Phase 5 Product Validation Review	Validation activities, Technical Documentation and DHF

Previous Reserves

All reserves from Phase 2 have been addressed and closed.

N°	Issue from Phase 2	Resolution	Status
-	No reserves	-	-

Version Information

• Version: 1.1.0.0
• Version type: Major (substantial changes to intended use and functionality)
• Git tag: release/1.1.0.0
• Release branch: release/1.1.0.0
• Release Candidate: RC-1.1.0.0
• Build date: [Date to be completed]

Version Objectives

This release includes:

• Enhanced AI/ML models for improved diagnostic accuracy
• Expanded dermatological condition coverage
• Improved user interface for clinical workflows
• Enhanced cybersecurity controls
• Regulatory compliance improvements for EU MDR and FDA requirements

Changelog

Key changes implemented in this version:

• Implementation of all Software Requirements from R-TF-012-023
• AI/ML model updates as per R-TF-028-002
• Security enhancements per R-TF-030-002
• Risk control measures implemented from R-TF-013-002

Software Development Outputs Checklist

Implementation Status

Component	Status	Evidence	Comments
All Software Requirements implemented	✓	Implementation traceable via GitHub Pull Requests linked to SRS Issues	Complete implementation verified
Software architecture realized	✓	Architecture implemented as designed in R-TF-012-023	Architecture consistency maintained
Risk control measures implemented	✓	Controls from R-TF-013-002 implemented in code	All safety controls in place
Security controls implemented	✓	Controls from R-TF-030-003 implemented	Cybersecurity measures active
AI/ML components developed	✓	Per R-TF-028-005	ML models trained and integrated
SOUP components integrated	✓	All SOUP from R-TF-012-023 verified and integrated	SOUP functioning correctly
User interface implemented	✓	UI requirements implemented per SRS	Interface ready for usability testing

Development Process Compliance

Activity	Status	Evidence	Comments
Agile sprints completed	✓	Sprint documentation in GitHub Projects	All planned sprints completed
Code reviews performed	✓	All Pull Requests reviewed and approved	Quality gates passed
Unit testing completed	✓	Unit test results available in CI/CD pipeline	Test coverage meets requirements
Integration testing completed	✓	Integration tests passed	Components integrated successfully
Configuration management maintained	✓	Per R-TF-012-023 configuration plan	Version control and branching strategy followed
Traceability maintained	✓	PR → SRS → Implementation linkage via GitHub	Full traceability chain intact

Test Plan Readiness

Verification Test Planning

Document	Status	Reference	Comments
Software Test Plan	✓	R-TF-012-033	Test strategy and test cases ready
Software Test Description	✓	R-TF-012-034	Detailed test procedures ready for execution
Test environment prepared	✓	Pre-production environment configured and validated	Environment ready for testing
Test data prepared	✓	Test datasets available	Data meets testing requirements
Regression test strategy defined	✓	Regression approach documented in test plan	Critical paths identified for regression

AI/ML Development Outputs

Document	Status	Reference	Responsible	Comments
AI/ML Development Report	✓	R-TF-028-005	JD-017	Model training and development documented
Data Collection completed	✓	Per R-TF-028-003	Datasets collected and curated
Data Annotation completed	✓	Per R-TF-028-004	Annotations complete and validated
Model performance evaluated	✓	Performance metrics documented in development report	Models meet performance requirements

Parallel Procedures Progress

Risk Management

Activity	Status	Evidence	Comments
Risk Management Record updated	✓	R-TF-013-002	All identified risks documented and controlled
Risk controls implemented and verified	✓	Controls traceable to implementation	Risk mitigation measures active
New risks identified during development	✓	Any new risks added to risk matrix	Risk assessment up to date

Cybersecurity

Activity	Status	Evidence	Comments	Responsible
Security controls implemented	✓	R-TF-030-003	All security requirements implemented	JD-007
Threat mitigation measures active	✓	Threats from R-TF-030-002 mitigated	Security posture improved	JD-007
Vulnerability assessments ongoing	✓	Security testing planned for Phase 4	Ready for penetration testing	JD-007

Usability

Activity	Status	Evidence	Comments
Formative usability evaluation completed	✓	R-TF-025-002	Formative feedback incorporated
UI implementation reflects usability findings	✓	Design improvements implemented	Interface optimized based on feedback
Summative usability testing planned	✓	Planned for Phase 5 validation	Ready for final usability validation

Clinical Evaluation

Activity	Status	Evidence	Comments
Clinical data collection ongoing	✓	Per R-TF-015-008	Clinical evaluation in progress
Clinical investigation planned	✓	Study protocols prepared	Ready for clinical validation Phase 5

Release Candidate Quality Gates

Quality Gate	Status	Comments
All SRS implemented	✓	Implementation complete and traceable
Code quality standards met	✓	Linting, formatting, and code review passed
Unit test coverage adequate	✓	Coverage meets minimum requirements
Integration tests passed	✓	All components integrated successfully
Build process successful	✓	Release candidate built without errors
No critical bugs open	✓	All critical issues resolved
Configuration management compliant	✓	Version control and release tagging correct
Documentation updated	✓	DHF current with all changes

Design History File (DHF) Status

Item	Status	Comments
All development artifacts documented	✓	Complete documentation trail maintained
Traceability matrix updated	✓	PR → SRS → Implementation → Test Cases
Change control records complete	✓	All changes tracked and approved
DHF organized and accessible	✓	Documentation readily available for review

IEC 62304 Compliance (Development Phase)

Requirement	Status	Evidence
5.4 Detailed design documented (if Class C)	N/A	Class B - detailed design optional
5.5 Software unit implementation and verification	✓	Unit tests executed and passed
5.6 Software integration and testing	✓	Integration strategy followed, tests passed
Problem resolution process followed	✓	Bug tracking and resolution via GitHub Issues

Reserves and Pending Actions

N°	Issue / Action Required	Owner	Targeted Date	Status
-	No reserves identified at this phase	-	-	-

Conclusion

Review Outcome: The Phase 3 Software Development review has been successfully completed.

Assessment:

• Release Candidate 1.1.0.0 has been built successfully
• All Software Requirements have been implemented and are traceable
• Software architecture has been realized as designed
• Risk control measures and security controls are implemented
• AI/ML components have been developed and integrated
• Code quality gates have been passed
• Integration testing completed successfully
• Test plans and test descriptions are ready for verification
• Parallel procedures (risk management, cybersecurity, usability, clinical) are progressing appropriately
• Design History File is up to date and complete
• Configuration management is compliant
• No critical open issues remain

Decision: The Release Candidate is approved to proceed to Phase 4: Software Verification.

Next Steps:

• Software Testing Team to execute verification testing per R-TF-012-033
• Document test results in R-TF-012-035
• Identify and assess any residual anomalies
• Prepare for Phase 4 verification review

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Approved by:

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