Design (Phase 1) Review
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) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Checklist
1. Requirements Analysis
- Have all system requirements been clearly defined and documented?
- Are the requirements traceable to user needs and intended use?
- Have all safety-related requirements been identified?
2. Risk Management
- Has a risk management plan been established?
- Are all identified risks documented and mitigated?
- Are risk control measures traceable to requirements?
3. Software Architecture
- Has the software architecture been defined and documented?
- Does the architecture address safety and performance requirements?
- Are interfaces between software components clearly defined?
4. Design Inputs
- Are design inputs complete, unambiguous, and verifiable?
- Do design inputs comply with applicable standards and regulations?
- Are design inputs traceable to system requirements?
5. Design Outputs
- Are design outputs documented and reviewed?
- Do design outputs meet the design input requirements?
- Are design outputs sufficient for verification and validation activities?
6. Verification and Validation
- Has a verification plan been established?
- Are verification activities traceable to design outputs?
- Has a validation plan been established?
7. Documentation
- Are all design documents complete and up-to-date?
- Are documents stored in a controlled and accessible manner?
- Have all documents been reviewed and approved?
8. Review and Approval
- Has the design been reviewed by all relevant stakeholders?
- Have all review comments been addressed?
- Has the design been formally approved?
Changelog
Admonitions
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