R-TF-012-039 Validated Version Transfer

Document Information

Field	Value
Product Name	Legit.Health Plus
Version	1.1.0.0
Transfer Date	2026-01-25
Document Prepared Date	2026-01-25

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 document is completed as part of Phase 5 (Product Validation) and, together with the R-TF-012-026 Product Validation Phase 5 Checklist, constitutes the closure of Phase 5 and authorizes the release of the validated software version for market deployment.

Phase 5 Workflow per GP-012

According to GP-012 (Design, Redesign and Development), Phase 5 begins once the software has been verified in Phase 4 and no known anomalies with unacceptable risk exist. Phase 5 encompasses all the following activities, which are reviewed and documented before closure:

1. Clinical Evaluation (GP-015): Complete the Clinical Evaluation Report demonstrating clinical safety and performance
2. Usability Summative Evaluation (GP-025): Confirm usability goals achieved with no critical use errors
3. Final Risk Management Review (GP-013): Complete the "Verification of Effectiveness" column in the Risk Management Record to confirm all risk control measures are effective
4. Commissioning (GP-029): Validate device performs correctly in the production environment
5. Post-Commissioning Risk Review: Confirm no new risks were identified during commissioning activities

Phase 5 Closure Documents:

• R-TF-012-026 Product Validation Phase 5 Checklist: Records the review of all Phase 5 activities
• R-TF-012-039 Validated Version Transfer (this document): Records the formal authorization for market release and Technical File closure

Upon approval of both closure documents, Phase 5 is complete, the Technical File for this version is closed, and the product is authorized for market release and regulatory submission.

Version Identification

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)

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.

Pre-Transfer Validation Checklist

Phase 5 Activities Completion

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

Activity	Status	Reference
Clinical Evaluation
Clinical Evaluation Plan	✓	R-TF-015-001 Clinical Evaluation Plan
Clinical Evaluation Report	✓	R-TF-015-003 Clinical Evaluation Report
Clinical Investigation (if applicable)	✓	R-TF-015-005 Clinical Investigation Reports
Usability
Usability Summative Evaluation Report	✓	R-TF-025-007 Summative evaluation report
Usability Plan	✓	R-TF-025-001 Usability plan
Final Risk Management Review
Risk Management Record (VoE completed)	✓	R-TF-013-002 Risk Management Record
Risk Management Report	✓	R-TF-013-003 Risk Management Report
Risk-Benefit Analysis favorable	✓	R-TF-013-003 Risk Management Report
Commissioning
Deployment & Configuration Commissioning	✓	R-TF-029-001
Functional & Interface Commissioning	✓	R-TF-029-002
Clinical Workflow Commissioning	✓	R-TF-029-003
Post-Commissioning Risk Review
No new risks identified in commissioning	✓	Phase 5 Review Meeting
Risk Management File closure confirmed	✓	R-TF-013-003 Risk Management Report

For more information about Phase 5 activities, see the GP-012 Design, Redesign and Development procedure.

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

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

Regulatory Compliance Confirmation

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	✓	R-TF-015-003 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

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	✓	R-TF-012-038 Verified Version Release
Cybersecurity Documentation	✓	R-TF-030-001 Cyber Security Management Plan

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)	✓	R-TF-030-001 Cyber Security Management Plan
IEC 62366-1 (Usability)	✓	R-TF-025-001 Usability plan

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.

Note: According to the European Commission guidance document "MDR - Language requirements for manufacturers" (Rev. 3, August 2025), language requirements vary by Member State and depend on whether the device is intended for professional users only or also for lay users. Legit.Health Plus is intended exclusively for healthcare professionals (professional users).

For more detailed information on language requirements per Member State, see the GP-022 Document Translation procedure.

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

Language Requirements Compliance:

• IFU available in English?: Yes
• Additional IFU translations provided where required (e.g., France)?: Yes
• Label translations completed for target markets?: Yes

Transfer Artifacts

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

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

Production Environment Confirmation

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

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)	✓	R-TF-007-002 PMCF Plan
Customer support infrastructure ready	✓	Support procedures
Vigilance reporting procedures established	✓	GP-007
Complaint handling procedures established	✓	GP-006

Transfer Authorization

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	✓

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.

Approvals

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

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 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager