R-TF-012-021 Product Design Phase 1 Checklist
Process Overview
The purpose of the Product Design review (Phase 1) is to ensure that the outputs of Product Design satisfy the criteria required to move forward to Phase 2 (Software Design). This review validates that the product concept, intended use, and high-level requirements are clearly defined and ready for technical implementation.
According to GP-012, Phase 1 establishes the foundation for all subsequent development phases.
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: 2025-11-10
- Reviewers: JD-001 (General Manager), JD-003 (Design & Development Manager), JD-007 (Technical Manager), JD-004 (Quality Manager & PRRC)
Context of Initialization
This project was initiated to develop Legit.Health Plus Version 1.1.0.0, a medical device software designed for dermatological diagnosis and disease tracking. The device addresses the medical need for objective, consistent, and scalable assessment of skin conditions using AI/ML-powered image analysis.
Key technological elements include:
- Machine learning models for skin condition recognition
- Image processing and analysis
- User interface for clinicians
- Integration with healthcare systems
This is an evolution of previous versions, incorporating regulatory compliance improvements and enhanced functionality for EU MDR and FDA requirements.
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 |
Product Design Checklist
Device Description and Intended Use
| Item | Status | Reference |
|---|---|---|
| Description of the Intended Use | ✓ | R-TF Device Description and Specification |
| Device Description (operating principles, core functions) | ✓ | R-TF Device Description and Specification |
| STED (Summary of Technical Documentation) | ✓ | R-TF Summary of Technical Documentation (STED) |
Product Requirements
| Item | Status | Reference | Comments |
|---|---|---|---|
| List of product requirements documented | ✓ | R-TF-012-031 Product Requirements Specification | Product Requirements (PRs) are defined and documented |
| Requirements are complete | ✓ | All stakeholder needs addressed | |
| Requirements are understandable | ✓ | Clear language, no ambiguity | |
| Requirements are consistent | ✓ | No contradictions between requirements | |
| Requirements are feasible | ✓ | Technically and commercially viable | |
| Requirements do not contradict one another | ✓ | Internal consistency verified | |
| Requirements are uniquely identified | ✓ | Each requirement has unique identifier | |
| Requirements are traceable to intended use | ✓ | Traceability maintained throughout |
Medical Device Classification
| Item | Status | Value | Reference |
|---|---|---|---|
| Device meets definition of medical device | ✓ | Yes | R-TF Device Description and Specification |
| Estimated medical device class (EU MDR) | ✓ | Class IIb | R-TF Device Description and Specification |
| Estimated medical device class (FDA) | ✓ | Class II | R-TF-012-040 Documentation level FDA |
| Estimated software class (IEC 62304) | ✓ | Class B | R-TF-012-041 Software Classification 62304 |
| Estimated software class (FDA) | ✓ | Level of Concern: Moderate | R-TF-012-040 Documentation level FDA |
Stakeholder Requirements Analysis
According to IEC 62304 and MDR 2017/745, product requirements must address all stakeholder needs. The following stakeholders have been identified and their requirements captured:
Internal Stakeholders (Company)
| Stakeholder | Category | Engagement Status | Requirements Contribution |
|---|---|---|---|
| JD-001 (General Manager) | Business | ✓ | Business strategy and market requirements |
| JD-003 (Design & Development Mgr) | Regulatory | ✓ | Regulatory requirements and product requirements definition |
| JD-007 (Technical Manager) | Technical | ✓ | Technical feasibility and high-level architecture |
| JD-004 (Quality Manager & PRRC) | Quality | ✓ | Quality requirements and compliance verification |
| JD-018 (Clinical Affairs) | Clinical | ✓ | Clinical needs and clinical evidence requirements |
External Stakeholders (Users, Patients, Regulatory, Market)
| Stakeholder Type | Category | Engagement Status | Requirements Contribution |
|---|---|---|---|
| Primary Users (Clinicians) | End User | ✓ | Usability requirements, clinical workflow needs, interface requirements |
| Patients | Patient | ✓ | Safety requirements, data privacy, patient-centric outcomes |
| Regulatory Bodies (EU, FDA) | Regulatory | ✓ | Compliance requirements (MDR, FDA 510(k)), safety standards |
| Target Markets (EU/EEA, USA) | Market | ✓ | Regional requirements, language, local regulations |
| Healthcare Institutions | Customer | ✓ | Integration requirements, technical specifications |
| Notified Body | Regulatory | ✓ | Technical documentation requirements, conformity assessment |
Stakeholder Requirements Coverage:
- ✓ User needs captured through usability studies and clinical feedback
- ✓ Patient safety requirements incorporated through risk management
- ✓ Regulatory requirements identified for EU MDR (Class IIb) and FDA (Class II)
- ✓ Market-specific requirements analyzed for target regions
- ✓ Clinical requirements validated by clinical affairs team
- ✓ Business and company requirements aligned with product strategy
Documentation Completeness
| Document | Status | Reference |
|---|---|---|
| Device Description and Specifications | ✓ | R-TF Device Description and Specification |
| STED | ✓ | R-TF Summary of Technical Documentation (STED) |
| Product Requirements (within SDP) | ✓ | R-TF-012-031 Product Requirements Specification |
Reserves and Pending Actions
| N° | Issue / Action Required | Owner | Targeted Date | Status |
|---|---|---|---|---|
| - | No reserves identified at this phase | - | - | - |
Conclusion
Review Outcome: The Phase 1 Product Design review has been successfully completed.
Assessment:
- All design inputs and outputs are complete, available, and relevant
- The device description and intended use are clearly documented
- Product requirements are comprehensive, traceable, and feasible
- Medical device and software classifications have been determined
- All stakeholders have been engaged and provided input
Decision: The project is approved to proceed to Phase 2: Software Design.
Next Steps:
- Initiate Software Design activities as defined in GP-012
- Begin development of Software Requirements Specification (SRS)
- Establish software architecture and design documents
- Initiate parallel procedures: Risk Management, Clinical Evaluation, Cybersecurity, AI/ML Development, and Usability
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