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    • GP-001
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      • R-012-004 Software version release for Brazil
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  • GP-012
  • R-012-004 Software version release for Brazil

R-012-004 Software version release for Brazil

This is a draft

This document is a draft version. This software version will be officially approved and released once the ANVISA approval is obtained.

Software name and version​

  • Software name: Legit.Health Plus
  • Software version to be released: Version 1.0.0.0
  • Previous software version: Not applicable

Requirements​

All the requirements associated with this software version release are approved and stored in the DHF folder Version 1.0.0.0.

The approved requirements that have been reviewed as part of this software release are:

  • REQ_001 The user receives quantifiable data on the intensity of clinical signs
    • Version (commit): bb7c9d43
    • Date of approval: 2024-11-14
  • REQ_002 The user receives quantifiable data on the count of clinical signs
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_003 The user receives quantifiable data on the extent of clinical signs
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_005 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_006 The data that users send and receive follows the FHIR healthcare interoperability standard
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_007 If something does not work, the API returns meaningful information about the error
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_008 Notify the user if the image does not represent a skin structure
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_009 Notify the user if the quality of the image is insufficient
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_010 The device detects if the image is of clinical or dermatoscopic modality
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_011 The user specifies the body site of the skin structure
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • REQ_012 Users can easily integrate the device into their system
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
info

The Design History File (DHF) is stored and maintained in GitHub, therefore the version of the documents contained in the DHF corresponds to the last commit of approval. More details about the control of documents are provided in the internal procedure GP-001 Control of documents.

Requirements verification​

All the test runs associated with this software version release successfully passed, are approved and stored in the DHF folder Version 1.0.0.0.

The approved test runs that have been reviewed as part of this software release are:

  • TEST_001 The user receives quantifiable data on the intensity of clinical signs
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_002 The user receives quantifiable data on the count of clinical signs
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_003 The user receives quantifiable data on the extent of clinical signs
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_007 If something does not work, the API returns meaningful information about the error
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_008 Notify the user image modality and if the image does not represent a skin structure
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_009 Notify the user if the quality of the image is insufficient
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_010 The user specifies the body site of the skin structure
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_011 We facilitate the integration of the device into the users' system
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_012 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_013 The data that users send and receive follows the FHIR healthcare interoperability standard
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST-014 The user authentication feature is functioning correctly
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_015 Ensure all API communications are conducted over HTTPS
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_016 Ensure API compliance with Base64 image format and FHIR standard
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_017 Verification of authorized user registration and body zone specification in device API
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14
  • TEST_018 Ensure API stability and cybersecurity of the medical device
    • Version (commit): b7c9d43
    • Date of approval: 2024-11-14

Software technical specifications​

Detailed software technical specifications are provided in the record R-TF-012-006 Lifecycle plan and report.

Additionally, the table below lists the specific version (or commit) of the microservices that comprise this system-level version of the medical device:

Microservice nameCode repositoryVersion (or commit)
Web API gatewayhttps://bitbucket.org/legithealth/web-api-receiver/src/main/67538d8fe

Known residual anomalies​

We confirm that the software version to be released has been thoroughly evaluated, with no residual anomalies detected. All quality checks have been completed, ensuring the software meets all performance and safety requirements for its intended use.

Final checklist​

After reviewing the evidence defined by the company’s Quality Management System, I (JD-005) can verify the following checks:

  • All the identified risks have been evaluated, addressed and reduced as far as possible.
  • Design control traceability is well-documented and maintained as part of the technical documentation.
  • The Technical Documentation is up to date.
  • All the verification and validation activities have been perfomed according to established plans and successfully passed.
  • Label is correctly applied.
  • The medical device complies with all the applicable regulatory and legislative requirements for medical device in Brazil (RDC No. 751, RDC No. 657, RDC No. 546).
  • The medical device has obtained the required regulatory approval (ANVISA registration)
  • If the software release includes significant change, Notified Body has been informed.

Technical manager (JD-005) statement​

All functional, performance, and safety requirements for this software version have been thoroughly verified and validated in accordance with the applicable standards, regulatory guidelines, and internal quality processes. The release of this version will be finalized upon obtaining ANVISA registration, ensuring compliance with all regulatory obligations for market entry in Brazil.

Record signature meaning​

  • Approver: JD-005 Alfonso Medela
Previous
R-001-002 Manufacturer declaration of conformity for Brazil
  • Software name and version
  • Requirements
  • Requirements verification
  • Software technical specifications
  • Known residual anomalies
  • Final checklist
  • Technical manager (JD-005) statement
  • Record signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)