REL-001 Version 1.1.0.0
Linked Requirements
- REQ_001 - The user receives quantifiable data on the intensity of clinical signs
- REQ_002 - The user receives quantifiable data on the count of clinical signs
- REQ_003 - The user receives quantifiable data on the extent of clinical signs
- REQ_004 - The user receives an interpretative distribution representing possible ICD categories in the image pixels
- REQ_005 - The user can send requests and receive the device output securely, efficiently and flexibly
- REQ_006 - All data exchanged follows the FHIR healthcare-interoperability standard
- REQ_007 - If something fails, the API returns meaningful error information
- REQ_008 - Notify the user if the image does not depict a skin structure
- REQ_009 - Notify the user if the image quality is insufficient
- REQ_010 - The device detects whether the image is clinical or dermatoscopic modality
- REQ_011 - The user specifies the body-site of the skin structure
- REQ_012 - We facilitate integration of the device into the users' system
Release Metadata
| Field | Value |
|---|---|
| Prior version / UDI | None |
| New version / UDI | 1.1.0.0 |
| Supervisor | JD-005 |
| Start date | 2 Oct 2023 |
| End date | 5 Oct 2023 |
Verifications
After reviewing the evidence defined by the company's Quality Management System, the following checks are verified:
- The quality controls indicated in the Technical Documentation have been carried out with satisfactory results.
- The medical device is fully safe to use.
- The medical device complies with regulatory and legislative requirements (European MDR 2017/745) and other applicable regulations according to its Technical Documentation.
- The medical device complies with its intended use and the product-quality standard.
- As manufacturers we are providing adequate data.
Technical Specifications
This release encompasses 12 requirements focused on designing a medical device that supports healthcare professionals in diagnosing dermatosis and facial palsy. Comprehensive instructions for use are available in the documentation referenced by REQ_012 (“We facilitate the integration of the device into the users' system”) and can be accessed at Table of contents | Legit.Health Plus Instructions For Use.
For more extensive information, consult R-TF-012-006 Lifecycle Plan and Report_2023_001 which defines the techniques, tools, resources, and activities associated with the development of the Legit.Health Plus medical device. This approach ensures alignment with ISO 62304:2007/A1:2016.
Known Residual Abnormalities
No residual abnormalities have been detected in this version. The device has undergone rigorous testing and quality-assurance procedures; all functionalities have been thoroughly reviewed and verified to perform as intended without identified abnormalities.
Version Release
As the Technical Manager, Alfonso Medela releases the new version of the medical device.
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