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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
      • R-TF-025-001 Usability plan
      • R-TF-025-002 Identification of characteristics for safety and possible use errors
      • R-TF-025-003 User interface evaluation plan
      • R-TF-025-004 Summative evaluation protocol
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Legit.Health Plus Version 1.1.0.0
  • Usability and Human Factors Engineering
  • R-TF-025-003 User interface evaluation plan

R-TF-025-003 User interface evaluation plan

Scope​

This document only applies to the medical device: Legit.Health Plus (hereinafter, the device). The purpose of this document is to plan the methods and techniques used to develop, explore, evaluate, and confirm the user interface design of the device.

This plan should be reviewed, updated, and approved according to changes in design and development.

Formative evaluation​

The purpose of formative evaluation is to verify that the user interface is recognizable, understandable, and usable.

During the design and development process, formative evaluation will take place iteratively according to GP-025 Usability and Human Factors Engineering and GP-012 Design, redesign and development. It will allow to progressively determine which elements of the user interface need to be improved or redefined.

The formative evaluation will take place during the sprint review at the end of each sprint. The JD-017 and JD-003 are responsible for the formative evaluation. They can also invite stakeholders (such as KOL, healthcare professionals, and other persons from outside the team), to be part of the review.

The formative evaluation will be performed with the presentation of mockups or prototypes by demonstrating the functionality in an in-person or remote screen-sharing session.

User tests on representative intended users may also be carried out on software prototypes.

Depending on the results of the evaluation, user interface specifications can be added to the backlog and implemented in another iteration.

Summative evaluation​

The purpose of the summative evaluation is to confirm that end users of the device can interact with the device safely and effectively and that the use of the product does not induce unacceptable harm.

The summative evaluation will take place at the end of the design and development of the device. It will be based on the findings of various combined methods. The aim is to guarantee the usability of the medical device for all intended user groups defined in Description and specifications.

Summative evaluation protocol​

For both user groups, Health Care Practitioners (HCP) and Information Technology Practitioners (ITP), the summative evaluation of the device will be realized by conducting user tests with representative members of each user group.

These tests will be combined with a medical device evaluation questionnaire to gather quantitative data on the device usability.

The document R-TF-025-004 Summative evaluation protocol describes the protocol for the user tests and the questionnaire that will be implemented for the summative evaluation.

It contains the following information:

  • The goal of the evaluation;
  • The user profiles participating in the evaluation;
  • The hazard-related scenarios evaluated;
  • The environment and duration of the evaluation.

Summative evaluation report​

The document R-TF-025-007 Summative evaluation report summarizes the results of the user tests and questionnaire conducted for the summative evaluation.

The summative evaluation report contains the following information:

  • A summary of the summative evaluation results;
  • Detailed results of the evaluation containing the participants' characteristics, detailed results of the user tests, and of the questionnaires.

Planning​

The planning of the usability evaluations is part of a global product development planning handled by the CPO. The main tasks and milestones of the project are managed in the overall project schedule.

The project roadmap is described in Jira, as described in GP-012 Design, redesign and development. The JD-017 regularly reviews its content with the JD-005.

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
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R-TF-025-002 Identification of characteristics for safety and possible use errors
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R-TF-025-004 Summative evaluation protocol
  • Scope
  • Formative evaluation
  • Summative evaluation
    • Summative evaluation protocol
    • Summative evaluation report
    • Planning
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.)