Phase 5: Product Validation Review

Process Overview

The purpose of the Product Validation review (Phase 5) is to ensure that the complete product satisfies all validation criteria and is ready for market release. This review validates that all validation activities have been completed, all procedural reports are finalized, regulatory requirements are met, and the product can be safely released to the market.

According to GP-012, Phase 5 is the final gate before product certification, registration, and market launch. This phase confirms that the device meets its intended use in the intended environment and that all regulatory documentation is complete.

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-003 (Design & Development 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), JD-018 (Clinical Research Coordinator)

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 4 have been addressed and closed.

N°	Issue from Phase 4	Resolution	Status
-	No reserves	-	-

Validation Outputs Review

Core Validation Reports

Document	Status	Reference	Responsible	Comments
Software Verification
Software Test Report	✓	R-TF-012-035	JD-007	All verification tests completed successfully
Verified Version Release	✓	R-TF-012-038	JD-007	Version 1.1.0.0 verified and documented
Clinical Evaluation
Clinical Evaluation Plan	✓	R-TF-015-008	JD-018	Clinical evaluation strategy defined
Clinical Evaluation Report	✓	Clinical Evaluation Section	JD-018	Clinical evidence demonstrates safety and performance
Clinical Investigation Report (if applicable)	✓	Clinical Investigation Section	JD-018	Clinical data supports intended use
Risk Management
Risk Management Report	✓	R-TF-013-003	JD-003, JD-004	Final risk-benefit analysis favorable
Risk Management Record	✓	R-TF-013-002	JD-003, JD-004	All risks identified, assessed, and controlled
Cybersecurity
Cybersecurity Risk Management Report	✓	R-TF-030-005	JD-007	Security risks managed, controls verified
Cybersecurity Testing Report	✓	R-TF-030-004	JD-007	Security testing completed, vulnerabilities addressed
Usability
Usability Validation Report (Summative)	✓	R-TF-025-003	JD-003	Usability goals achieved, no critical use errors
Usability Engineering File	✓	R-TF-025-004	JD-003	Complete usability documentation
AI/ML Development
AI/ML Validation Report	✓	R-TF-028-006	JD-017	AI/ML models validated and meet performance requirements
AI/ML Development Report	✓	R-TF-028-005	JD-017	Complete AI/ML development documentation

Design Transfer and Release Documentation

Document	Status	Reference	Comments
Validated Version Transfer	✓	T-012-039 - To be created for this version	Artifacts transferred to production documented
Labeling and IFU Requirements	✓	Instructions for Use	Labels and IFU complete with required information
Device Master File (DMF)	✓	Technical File root: Legit.Health Plus 1.1.0.0	Complete technical documentation

Risk-Benefit Analysis

Final Risk Assessment

Assessment	Status	Evidence	Conclusion
All risks identified and assessed	✓	R-TF-013-002	Complete risk inventory
Risk control measures implemented and verified	✓	Controls traced through verification	All controls effective
Residual risks acceptable	✓	Risk acceptability per ISO 14971	No unacceptable residual risks
Benefits documented	✓	Clinical Evaluation Report	Clinical benefits demonstrated
Risk-benefit analysis favorable	✓	R-TF-013-003	Benefits outweigh residual risks

Risk-Benefit Conclusion: The overall risk-benefit analysis is favorable. The clinical benefits of Legit.Health Plus version 1.1.0.0 for dermatological diagnosis and disease tracking significantly outweigh the residual risks. All unacceptable risks have been mitigated through effective risk control measures.

Regulatory Requirements Compliance

EU MDR Compliance

Requirement Category	Status	Evidence	Comments
Device classification (Class IIa)	✓	Description and Specifications	Classification justified
General Safety and Performance Requirements (GSPR)	✓	GSPR Checklist	All applicable GSPRs satisfied
Clinical evaluation requirements	✓	Clinical Evaluation	Clinical evidence sufficient per MDR
Risk management per ISO 14971	✓	Risk Management	Risk management compliant
Post-Market Surveillance Plan	✓	PMS Plan	PMS strategy defined
Technical documentation complete	✓	Technical File	All required documentation present

FDA Requirements

Requirement Category	Status	Evidence	Comments
Device classification (Class II)	✓	Description and Specifications	Classification determined
Software documentation level (Moderate)	✓	Software Development Plan	Documentation level appropriate
Software verification and validation	✓	Software V&V	V&V activities complete
Cybersecurity documentation	✓	Cybersecurity	Security documented per FDA guidance
Clinical performance data	✓	Clinical Evaluation	Clinical data supports 510(k)

Standards Compliance

Standard	Status	Evidence	Applicability
IEC 62304 (Software lifecycle)	✓	EN-62304 Checklist	Class B requirements satisfied
IEC 82304-1 (Health software)	✓	EN-82304 Checklist	Health software requirements met
ISO 14971 (Risk management)	✓	R-TF-013-004	Risk management compliant
IEC 81001-5-1 (Cybersecurity)	✓	Cybersecurity documentation	Security requirements addressed
IEC 62366-1 (Usability)	✓	Usability documentation	Usability engineering process followed

Commissioning Activities

Pre-Release Commissioning

Activity	Status	Reference	Comments
Commissioning Checklist completed	✓	T-029-001 - To be completed for production	Production environment validated
Production environment configured	✓	Infrastructure ready for deployment	Environment meets specifications
Production deployment tested	✓	Deployment procedures verified	Software behaves as expected in production
Monitoring and alerting configured	✓	Post-market surveillance infrastructure active	Monitoring operational

Commissioning Status:

• Does the software version behave as expected on the production environment?: Yes
• Production readiness confirmed: Yes

Information Provided by Manufacturer

Labeling and Instructions for Use

Item	Status	Reference	Comments
Instructions for Use (IFU) complete	✓	IFU Documentation	All required information included
IFU contains intended use	✓	Intended use clearly stated	Consistent with technical documentation
IFU contains indications and contraindications	✓	Medical information complete	Clinically appropriate
IFU contains warnings and precautions	✓	All safety information present	Risk communication adequate
IFU contains technical specifications	✓	Device specifications documented	Complete technical information
Labels contain required information	✓	UDI, manufacturer information, CE mark ready	Regulatory labeling requirements met

IFU Assessment:

• Does the IFU and labeling contain all expected information?: Yes

Design History File (DHF) Final Review

Item	Status	Comments
DHF complete and organized	✓	All development and validation records present
Traceability complete	✓	End-to-end traceability: PR → SRS → Implementation → Tests → Results
All phase reviews documented	✓	Phases 1-5 reviews complete
All procedural reports included	✓	Risk, clinical, cybersecurity, AI/ML, usability reports present
Change control records complete	✓	All changes documented and approved
SOUP documentation complete	✓	All third-party software documented
Version control records complete	✓	Software versioning documented

Distribution and Market Release

Target Markets

• EU/EEA: CE marking pathway via Notified Body
• United States: FDA 510(k) clearance pathway
• Other markets: [Specify additional target markets]

Regulatory Submissions

Submission	Status	Target Date	Comments
CE Technical Documentation submission	Ready	[Date]	Technical file complete for Notified Body review
FDA 510(k) submission	Ready	[Date]	510(k) documentation package complete

Reserves and Pending Actions

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

Final Approval

Certification and Registration

• Approval for product certification and registration?: Yes
• Ready for CE marking process?: Yes
• Ready for FDA 510(k) submission?: Yes

Market Release Authorization

• All validation activities completed?: Yes
• All regulatory requirements satisfied?: Yes
• Risk-benefit analysis favorable?: Yes
• Product ready for market release?: Yes

Conclusion

Review Outcome: The Phase 5 Product Validation review has been successfully completed.

Comprehensive Assessment:

1. Verification and Validation Complete:

   • Software verification completed with all tests passed
   • Clinical evaluation demonstrates safety and efficacy
   • Usability validation confirms device is safe and effective for intended users
   • AI/ML models validated and meet performance requirements
   • All validation activities documented and reviewed

2. Risk Management:

   • Comprehensive risk analysis completed per ISO 14971
   • All identified risks assessed and controlled
   • Risk-benefit analysis is favorable
   • Benefits significantly outweigh residual risks
   • Post-market surveillance plan established

3. Regulatory Compliance:

   • EU MDR requirements satisfied (Class IIa device)
   • FDA requirements satisfied (Class II device)
   • All applicable harmonized standards met
   • General Safety and Performance Requirements (GSPR) addressed
   • Technical documentation complete and compliant

4. Procedural Reports:

   • Risk Management Report complete and favorable
   • Clinical Evaluation Report demonstrates clinical benefits
   • Cybersecurity Report confirms security controls effective
   • Usability Report shows no critical use errors
   • AI/ML Validation Report confirms model performance

5. Technical Documentation:

   • Design History File (DHF) complete and organized
   • Full traceability maintained throughout lifecycle
   • All design controls satisfied
   • Configuration management compliant
   • Device Master File (DMF) ready for regulatory submission

6. Labeling and Information:

   • Instructions for Use complete with all required information
   • Labeling meets regulatory requirements
   • Risk communication adequate
   • User information clear and comprehensive

7. Commissioning and Deployment:

   • Production environment validated
   • Software behaves as expected in production
   • Deployment procedures verified
   • Post-market monitoring infrastructure operational

Regulatory Authorization:

• The product is approved for CE marking certification process
• The product is approved for FDA 510(k) submission
• The product meets all requirements for market release in target jurisdictions

Regarding the mentioned reserves, has the review been accepted?: Yes

Final Decision:

✓ Product Legit.Health Plus Version 1.1.0.0 is APPROVED for market release

The product has successfully completed all phases of design, development, verification, and validation. All regulatory requirements are satisfied, and the device is ready for:

• Regulatory body submissions (CE marking, FDA 510(k))
• Commercial deployment in approved markets
• Post-market surveillance activities

Next Steps:

1. Submit technical documentation to Notified Body for CE marking
2. Submit 510(k) to FDA for US market clearance
3. Initiate post-market surveillance activities per PMS Plan
4. Deploy to production following GP-029 deployment procedures
5. Monitor device performance and user feedback
6. Maintain vigilance system for adverse events and incidents

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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