Phase 2: Software Design Review

Process Overview

The purpose of the Software Design review (Phase 2) is to ensure that all outputs of the Software Design phase satisfy the criteria required to proceed to Phase 3 (Software Development). This review validates that software requirements, architecture, test plans, and related procedural documents are complete and ready for implementation.

According to GP-012, Phase 2 establishes the input data for development and initiates parallel procedures for risk management, clinical evaluation, cybersecurity, AI/ML development, and usability.

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 1 have been addressed and closed.

N°	Issue from Phase 1	Resolution	Status
-	No reserves	-	-

Software Design Outputs Checklist

Software Planning and Specification Documents

Document	Status	Reference	Comments
Software Development Plan	✓	R-TF-012-023	Complete, includes methodology and planning
Software Requirements Specification (SRS)	✓	R-TF-012-023 Section 4	All SRS documented and traceable to PRs
Software Architecture Description	✓	R-TF-012-023 Section 5	Architecture defined with component interfaces
Software Configuration Management Plan	✓	R-TF-012-023 Section 3	Version control and branching strategy defined
Software Test Plan	✓	R-TF-012-033	Test strategy and test cases defined
Software Test Description	✓	R-TF-012-034	Detailed test procedures documented
Traceability Matrix (draft)	✓	R-TF-012-023 Section 10	PR → SRS → Test Cases traceability established
Software Classification (IEC 62304)	✓	R-TF-012-023 Section 2.3	Class B confirmed
SOUP Components List	✓	R-TF-012-023 Section 8	All SOUP components identified and assessed

Software Requirements Quality

Criterion	Status	Comments
Requirements are complete	✓	All functional and non-functional requirements documented
Requirements are understandable	✓	Clear, unambiguous language used
Requirements are traceable to Product Requirements	✓	Traceability matrix established (PR → SRS)
Requirements are testable	✓	Test criteria defined for each requirement
Requirements are uniquely identified	✓	Each SRS has unique identifier (GitHub Issues)
Requirements include user interface requirements	✓	UI/UX requirements documented
Requirements include cybersecurity requirements	✓	Security requirements traceable to Security Risks
Requirements include risk control measures	✓	Safety risk controls implemented in software documented

Parallel Procedures Initiated (Other Procedures Kickoff)

According to GP-012, Phase 2 initiates parallel procedures. The following plans have been established:

Procedure	Plan Document	Status	Responsible
Risk Management (GP-013)	R-TF-013-001 Risk Management Plan	✓	JD-003, JD-004
Risk Management Record	R-TF-013-002 Risk Management Record	✓	JD-003, JD-004
Clinical Evaluation (GP-015)	R-TF-015-008 Clinical Evaluation Plan	✓	JD-018
Cybersecurity (GP-030)	R-TF-030-002 Cybersecurity Plan	✓	JD-007
Cybersecurity Risk Matrix	R-TF-030-003 Security Risk Matrix	✓	JD-007
AI/ML Development (GP-028)	R-TF-028-002 AI/ML Development Plan	✓	JD-017
AI/ML Description	R-TF-028-001 AI/ML Description	✓	JD-017
AI/ML Design Checks	R-TF-028-009 AI/ML Design Checks	✓	JD-017
Usability (GP-025)	R-TF-025-001 Usability Plan	✓	JD-003

Validation Plans

Plan Document	Status	Reference	Responsible
Software Test Plan (Verification)	✓	R-TF-012-033	JD-007
Usability Validation Plan	✓	R-TF-025-001	JD-003
Clinical Evaluation Plan	✓	R-TF-015-008	JD-018

IEC 62304 Compliance Review

Planning (Class B Requirements)

Requirement	Status	Evidence
5.1 Software Development Plan established	✓	R-TF-012-023
5.1.6 Software Verification planning	✓	R-TF-012-033
5.1.9 Configuration Management documented	✓	R-TF-012-023 Section 3

Requirements Analysis (Class B)

Requirement	Status	Evidence
5.2 Software Requirements defined and documented	✓	R-TF-012-023 Section 4
5.2.3 Risk control measures in software	✓	Risk controls traceable in R-TF-013-002
Requirements complete and verifiable	✓	All SRS are testable and traceable

Architecture (Class B)

Requirement	Status	Evidence
5.3.1 Software Architecture documented	✓	R-TF-012-023 Section 5
5.3.2 Interfaces between software elements	✓	Component interfaces defined in architecture
5.3.3 SOUP functional requirements specified	✓	R-TF-012-023 Section 8
5.3.4 SOUP hardware/software requirements	✓	SOUP prerequisites documented
5.3.6 Architecture verification	✓	Architecture reviewed for consistency and feasibility

Risk Management Integration (Class B)

Requirement	Status	Evidence
7.1.1 Hazardous software elements identified	✓	R-TF-013-002
7.1.2-7.1.5 Software risk analysis performed	✓	Potential causes and sequences documented in Risk Management Record
7.2 Risk control measures documented	✓	Controls traceable to SRS and implementation

IEC 81001 (Cybersecurity) Compliance Review

Requirement	Status	Evidence
Security requirements defined	✓	R-TF-030-003
Threat model established	✓	R-TF-030-002
Security controls defined	✓	Security controls traceable to threats and SRS

Design History File (DHF) Status

Item	Status	Comments
DHF structure established	✓	All documentation organized and accessible
All Phase 2 outputs documented	✓	Complete documentation available
Document version control implemented	✓	Git-based version control active
Traceability established	✓	PR → SRS → Architecture → Test Cases

Reserves and Pending Actions

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

Conclusion

Review Outcome: The Phase 2 Software Design review has been successfully completed.

Assessment:

• All software design outputs are complete, available, and relevant
• Software Requirements Specification (SRS) is comprehensive, traceable, and testable
• Software architecture is well-defined with clear component interfaces
• All required plans (verification, risk management, clinical, cybersecurity, AI/ML, usability) have been established
• SOUP components have been identified and assessed
• IEC 62304 Class B requirements are satisfied
• IEC 81001 cybersecurity requirements are addressed
• Traceability from Product Requirements to Software Requirements is established
• Design History File is properly organized and up-to-date

Decision: The project is approved to proceed to Phase 3: Software Development.

Next Steps:

• Begin agile iterative development sprints
• Implement software according to SRS and architecture
• Continue parallel procedures (risk management, clinical, cybersecurity, AI/ML, usability)
• Maintain traceability throughout implementation
• Prepare for Phase 3 release candidate 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