R-TF-012-019 SOUP

Description

Instructions

Insert a brief description of the SOUP.

General details

• Developer(s):
• Open source:
• Language(s):
• Repository:
• License:
• Operating system(s):
• Actively maintained:
  • Yes
  • No

Intended use on the device

Instructions

Insert the intended use of the SOUP used in the medical device.

Requirements

For the integration and safe usage of this SOUP within a software system, it's important to outline both functional and performance requirements. These requirements help mitigate risks and ensure compatibility and performance standards are met.

Functional

Instructions

Insert the functional requirements of the SOUP.

Performance

Instructions

Insert the performance requirements of the SOUP.

System requirements

Establishing minimum software and hardware requirements is important to mitigate risks, such as security vulnerabilities, performance issues, or compatibility problems, and to ensure that the SOUP functions effectively within the intended environment.

Software

Instructions

Insert any software requirements to enable the use of the SOUP.

Hardware

Instructions

Insert any hardware requirements to enable the use of the SOUP.

Documentation

Instructions

Insert the location of the SOUP documentation.

Additionally, a criterion for validating the SOUP is that all the items of the following checklist are satisfied:

• The vendor maintains clear and comprehensive documentation of the SOUP describing its functional capabilities, user guidelines, and tutorials, which facilitates learning and rapid adoption.
• The documentation for the SOUP is regularly updated and clearly outlines every feature utilized by the medical device, doing so for all integrated versions of the SOUP.

Related software items

We catalog the interconnections between the microservices within our software architecture and the specific versions of the SOUP they utilize. This mapping ensures clarity and traceability, facilitating both the understanding of the system's dependencies and the management of SOUP components.

Although the title of the section mentions software items, the relationship with SOUP versions has been established with microservices (also considered software items) because each one is inside a different Docker container and, therefore, has its own isolated runtime environment.

SOUP version	Software item(s)

Related risks

The following are risks applicable to this SOUP coming from the document R-TF-013-002 Risk management record:

Instructions

Insert the risk(s) ID and description related to the SOUP.

List of published anomalies

Instructions

List the known anomalies related to the SOUP.

History of evaluation of SOUP anomalies

• Evaluation date: YYYY-MM-DD
• Reviewer of the anomalies:
• Version(s) of the SOUP reviewed:
• Anomalies:

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

Delete this

Delete this section when you create a new record from this template.

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