R-TF-012-039 Validated Version Transfer

Document Information

Field	Value
Product Name	Legit.Health Plus
Version	1.1.0.0
Transfer Date	[Date to be completed]
Document Prepared By	JD-003 (Design & Development Manager)
Document Prepared Date	[Date to be completed]
Reviewed By	JD-004 (Quality Manager & PRRC)
Review Date	[Date to be completed]
Approved By	JD-001 (General Manager)
Approval Date	[Date to be completed]

1. Purpose

This document records the formal transfer of Legit.Health Plus version 1.1.0.0 from development to production after successful completion of all validation activities. This transfer marks the conclusion of Phase 5 (Product Validation) and authorizes the release of the validated software version for market deployment.

2. Version Identification

2.1 Software Product Information

Field	Value
Product Name	Legit.Health Plus
Version Number	1.1.0.0
Release Type	Initial Release
Software Safety Class	Class B (per IEC 62304)
Medical Device Class	Class IIb (EU MDR) / Class II (FDA)
Verified Version Release	R-TF-012-038 Verified Version Release
Target Markets	All EU/EEA countries (27 EU Member States + Iceland, Liechtenstein, Norway)

2.2 Version Description

Legit.Health Plus version 1.1.0.0 is a Software as a Medical Device (SaMD) designed to assist healthcare professionals in dermatological diagnosis and disease tracking using AI/ML algorithms for image analysis of skin conditions.

3. Pre-Transfer Validation Checklist

3.1 Phase 5 Activities Completion

Per GP-012, the following Phase 5 activities must be completed before validated version transfer:

Activity	Status	Reference	Completion Date
Clinical Evaluation
Clinical Evaluation Plan	✓	R-TF-015-008 Clinical Evaluation Plan	[Date]
Clinical Evaluation Report	✓	Clinical Evaluation Section	[Date]
Clinical Investigation (if applicable)	✓	Clinical Investigation Section	[Date]
Usability
Usability Summative Evaluation	✓	R-TF-025-004 Summative Evaluation	[Date]
Usability Engineering File	✓	R-TF-025-001 Usability Plan	[Date]
Final Risk Management Review
Risk Management Record (VoE completed)	✓	R-TF-013-002 Risk Management Record	[Date]
Risk Management Report	✓	R-TF-013-003 Risk Management Report	[Date]
Risk-Benefit Analysis favorable	✓	R-TF-013-003 Risk Management Report	[Date]
Commissioning
Deployment & Configuration Commissioning	✓	R-TF-029-001	[Date]
Functional & Interface Commissioning	✓	R-TF-029-002	[Date]
Clinical Workflow Commissioning	✓	R-TF-029-003	[Date]
Post-Commissioning Risk Review
No new risks identified in commissioning	✓	Phase 5 Review Meeting	[Date]
Risk Management File closure confirmed	✓	R-TF-013-003 Risk Management Report	[Date]

3.2 Final Risk Management Review - Verification of Effectiveness

Per GP-013 and ISO 14971:2019, the "Verification of Effectiveness" column in the Risk Management Record (R-TF-013-002) has been completed to confirm that all risk control measures have been implemented and their effectiveness verified.

Review Item	Status	Evidence
All risks identified and assessed	✓	R-TF-013-002 Risk Management Record
All risk control measures implemented	✓	Traceability to verification tests
"Verification of Effectiveness" column completed for all controls	✓	R-TF-013-002 Risk Management Record
All residual risks within acceptable limits	✓	Risk acceptability per ISO 14971
No unacceptable new risks introduced by risk control measures	✓	R-TF-013-002 Risk Management Record

Verification of Effectiveness Confirmation:

• Are all risk control measures implemented?: Yes
• Has the effectiveness of each risk control measure been verified?: Yes
• Are all residual risks acceptable?: Yes

3.3 Post-Commissioning Risk Review

Per GP-013 and ISO 14971:2019, after commissioning activities were completed, a final review of the Risk Management File confirmed that no new risks were identified during commissioning in the production environment.

Review Item	Status	Evidence	Conclusion
New risks identified during deployment and configuration commissioning	✓	R-TF-029-001 review	No new risks identified
New risks identified during functional and interface commissioning	✓	R-TF-029-002 review	No new risks identified
New risks identified during clinical workflow commissioning	✓	R-TF-029-003 review	No new risks identified
Existing risk controls effective in production environment	✓	Commissioning results	All controls effective
Overall residual risk assessment remains valid	✓	R-TF-013-003	Risk-benefit analysis remains favorable

Post-Commissioning Risk Assessment:

• Were any new risks identified during commissioning activities?: No
• Were any existing risk control measures found to be ineffective in the production environment?: No
• Does the Risk Management File require updates?: No
• Risk Management File closure confirmed: Yes

4. Regulatory Compliance Confirmation

4.1 EU MDR Compliance

Requirement	Status	Evidence
Device Classification (Class IIb)	✓	R-TF Device Description and Specification
General Safety and Performance Requirements (GSPR)	✓	R-TF-008-001 GSPR Checklist
Clinical Evaluation per MDR	✓	Clinical Evaluation Report
Risk Management per ISO 14971	✓	R-TF-013-003 Risk Management Report
Technical Documentation complete	✓	Technical File
Post-Market Surveillance Plan	✓	R-TF-007-001 PMS Plan

4.2 FDA Compliance

Requirement	Status	Evidence
Device Classification (Class II)	✓	R-TF Device Description and Specification
Software Documentation Level (Moderate)	✓	R-TF-012-040 Documentation Level FDA
Software Verification and Validation	✓	V&V Documentation
Cybersecurity Documentation	✓	Cybersecurity Section

4.3 Standards Compliance

Standard	Status	Evidence
IEC 62304 (Software lifecycle)	✓	R-TF EN 62304 Checklist
IEC 82304-1 (Health software)	✓	R-TF EN 82304 Checklist
ISO 14971 (Risk management)	✓	R-TF-013-004 Checklist ISO 14971
IEC 81001-5-1 (Cybersecurity)	✓	Cybersecurity documentation
IEC 62366-1 (Usability)	✓	Usability Engineering File

4.4 Target Markets and Regional Requirements

Per EU MDR 2017/745 Article 10(11), the manufacturer shall ensure that the device is accompanied by the information required in Annex I, Section 23, in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.

Target Markets: All European Union (EU) and European Economic Area (EEA) countries.

Country/Region	Official Language(s)	IFU Translation	Label Translation	Status
Austria	German	✓	✓	✓
Belgium	Dutch, French, German	✓	✓	✓
Bulgaria	Bulgarian	✓	✓	✓
Croatia	Croatian	✓	✓	✓
Cyprus	Greek	✓	✓	✓
Czech Republic	Czech	✓	✓	✓
Denmark	Danish	✓	✓	✓
Estonia	Estonian	✓	✓	✓
Finland	Finnish, Swedish	✓	✓	✓
France	French	✓	✓	✓
Germany	German	✓	✓	✓
Greece	Greek	✓	✓	✓
Hungary	Hungarian	✓	✓	✓
Ireland	English, Irish	✓	✓	✓
Italy	Italian	✓	✓	✓
Latvia	Latvian	✓	✓	✓
Lithuania	Lithuanian	✓	✓	✓
Luxembourg	French, German, Luxembourgish	✓	✓	✓
Malta	Maltese, English	✓	✓	✓
Netherlands	Dutch	✓	✓	✓
Poland	Polish	✓	✓	✓
Portugal	Portuguese	✓	✓	✓
Romania	Romanian	✓	✓	✓
Slovakia	Slovak	✓	✓	✓
Slovenia	Slovenian	✓	✓	✓
Spain	Spanish	✓	✓	✓
Sweden	Swedish	✓	✓	✓
EEA Countries
Iceland	Icelandic	✓	✓	✓
Liechtenstein	German	✓	✓	✓
Norway	Norwegian	✓	✓	✓

Translation Requirements Compliance:

• Are all IFU translations completed for target markets?: Yes
• Are all label translations completed for target markets?: Yes
• Translation verification performed?: Yes

5. Transfer Artifacts

5.1 Software Artifacts for Production

Artifact	Status	Location/Reference
Software Release Package	✓	Production deployment repository
Configuration Files	✓	Production environment
Database Migration Scripts	✓	Production deployment package
AI/ML Model Packages	✓	Production model registry

5.2 Documentation Artifacts

Document	Status	Reference
Instructions for Use (IFU)	✓	Information Provided by Manufacturer Section
Technical File (EU MDR)	✓	Legit.Health Plus Version 1.1.0.0 Technical Documentation
Design History File (DHF)	✓	Design and Development Section
Device Master Record (DMR)	✓	Technical File
Risk Management File	✓	Risk Management Section
Clinical Evaluation Report	✓	Clinical Evaluation Section

6. Production Environment Confirmation

6.1 Commissioning Results

Environment Aspect	Status	Evidence
Production environment configured	✓	R-TF-029-001
Core functionalities verified	✓	R-TF-029-002
Clinical workflows validated	✓	R-TF-029-003
Performance within specifications	✓	Commissioning
Security controls operational	✓	R-TF-030-004

6.2 Post-Market Readiness

Readiness Item	Status	Reference
Post-Market Surveillance Plan in place	✓	R-TF-007-001 PMS Plan
PMCF Plan in place (if applicable)	✓	PMCF Plan
Customer support infrastructure ready	✓	Support procedures
Vigilance reporting procedures established	✓	GP-007
Complaint handling procedures established	✓	GP-006

7. Transfer Authorization

7.1 Transfer Checklist

Item	Status
All validation activities completed (Clinical, Usability Summative)	✓
Final Risk Management Review completed (Verification of Effectiveness)	✓
Commissioning activities completed (production environment validated)	✓
Post-Commissioning Risk Review completed (no new risks identified)	✓
All regulatory requirements satisfied	✓
Risk-benefit analysis favorable	✓
Post-market surveillance infrastructure ready	✓
Version 1.1.0.0 approved for market release	✓

7.2 Transfer Decision

Based on the successful completion of all Phase 5 validation activities, commissioning, and risk management reviews, Legit.Health Plus version 1.1.0.0 is hereby authorized for transfer to production and market release.

8. Approvals

8.1 Transfer Authorization Signatures

Role	Name	Signature	Date
Design & Development Manager	JD-003
Technical Manager	JD-007
Quality Manager & PRRC	JD-004
Clinical Research Coordinator	JD-018
General Manager	JD-001

8.2 Authorization Statement

We, the undersigned, confirm that:

1. All Phase 5 Product Validation activities have been completed satisfactorily
2. The Clinical Evaluation demonstrates adequate safety and performance
3. The Usability Summative Evaluation confirms no critical use errors
4. The Final Risk Management Review confirms all risk control measures are effective (Verification of Effectiveness completed)
5. Commissioning activities confirm the device performs as designed in the production environment
6. The Post-Commissioning Risk Review confirms no new risks were identified during commissioning
7. All regulatory requirements for EU MDR and FDA have been satisfied
8. The risk-benefit analysis is favorable
9. Legit.Health Plus version 1.1.0.0 is approved for market release

Transfer Effective Date: [Date to be completed]

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Document History

Version	Date	Author	Changes
1.0	[Date]	JD-003	Initial release