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