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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
      • Deprecated
      • Templates
        • T-012-001 Requirements
        • T-012-003 Test run
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-018 Test plan
        • T-012-019 SOUP
      • Specific procedures
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates
  • T-012-007 Formative evaluation plan_YYYY_nnn

T-012-007 Formative evaluation plan_YYYY_nnn

Purpose​

This document describes the usability evaluation process for the PRODUCT NAME medical device.

Responsibilities​

JD-003​

  • To coordinate the entire design and development process of the products.

JD-005​

  • To ensure that the entire process of usability evaluation of the products is carried out according to the methodology established in the present procedure.

JD-004​

  • To ensure that the usability evaluation is performed following this procedure, and that all the records required are properly generated, reviewed, approved and archived accordingly.

Terms and Definitions​

  • DHF: Design History File
  • Formative evaluation: user interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors.
  • Hazard-related use scenario: use scenario that could lead to a hazardous situation or harm.
  • Primary operating function: the function that involves user interaction that is related to the safety of the medical device.
  • QMS: Quality Management System.
  • Summative evaluation: user interface evaluation conducted at the end of the user interface development with the intent to obtain objective evidence that the user interface can be used safely.
  • Usability: characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment.
  • Use environment: actual conditions and settings in which users interact with the medical device.
  • Use error: user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user.
  • Use scenario: a specific sequence of tasks performed by a specific user in a specific use environment and any resulting response of the medical device.
  • Use or specification: summary of the important characteristics related to the context of use of the medical device.
  • User interface: means by which the user and the medical device interact.
  • User interface evaluation: the process by which the manufacturer explores or assesses the user interactions with the user interface.
  • User interface specification: a collection of specifications that comprehensively and prospectively describe the user interface of a medical device.

General information​

The actions aimed at demonstrating the usability of the device are carried out following the standard UNE-EN 62366-1:2015/A1:2020 and the results are registered in the corresponding usability reports R-TF-012-008 Formative evaluation report and R-TF-012-015 Summative evaluation report.

The associated reports are included in the corresponding technical file and they must be updated when the main version of the medical device software changes during the product lifecycle leading to a new usability test.

Inputs​

  • Risk management (according to procedure GP-013 Risk management). If we identify any new risks related to usability in the R-TF-013-002 Risk management record, we must create a new version of the R-TF-012-015 Summative evaluation report, collecting all this data, and generate a new strategy to comply with usability following the standard UNE-EN 62366-1:2015/A1:2020.
  • Feedback and complaints (according to procedure GP-014 Feedback and complaints) to look for new requirements that may require a product redesign related to usability.
  • The information generated by the performance of the post-market activities according to the GP-007 Post-market surveillance procedure, will be considered to identify possible interferences related to the usability of the medical device.
  • Any communication detected during the vigilance activities described at the GP-004 Vigilance system that can affect the usability of the product.
  • The clinical evaluation, which was performed according to the GP-015 Clinical evaluation procedure.
  • When the results require actions to prevent affecting the usability of the device, the guidelines indicated in the General Procedure GP-006 Non-conformity. Corrective and preventive actions will be used to determine, design, and document the actions.

Outputs​

  • To register the results of the formative evaluation, we create a report using the template R-TF-012-008 Formative evaluation report.
  • To register the results of the summative evaluation, we create a report using the template R-TF-012-015 Summative evaluation report.
  • A new entry will be generated in the R-TF-002-004 Annual management review report by the corresponding management referring to these changes in the QMS documentation.

Formative evaluation plan​

This section details our approach to the formative evaluation of the software, focusing on the identification and rectification of potential usability problems in early development stages, in line with EN 62366-1, 5.7.2.

Purpose​

The purpose of the formative evaluation plan is to identify potential usability problems and rectify them before the summative evaluation phase.

Characterization of the medical device​

  • Intended purpose:
  • Intended user:
  • Patient population:
  • Operating principle:
  • Body structure:
  • Indications:

Use specification​

Target user group​

Instructions

Insert the user group(s) selected for executing the formative evaluation test, including justification of the choice.

User profile​

Instructions

Insert the profile of the user group(s) in terms of experience, knowledge, background, expertise, training.

Use environment​

Instructions

Describe the environment where the device is intended to be used and the environment where the formative evaluation test will be executed (if it is different from the use environment defined for the use of the device).

Identification of the elements of the user interface​

Instructions

List and describe the elements of the user interface.

Methodology​

Instructions

Describe how the formative evaluation test will be executed, e.g. remote, in-person, number of iterations, expected number of participants, estimated time for test execution, materials to be provided to participants, method to collect feedback of participants.

Scenarios​

Instructions

Describe the test cases that the participants will be asked to execute during the formative evaluation test.

Evaluation questionnaire​

Instructions

Insert the questions provided in the evaluation questionnaire to collect feedback of participants.

Evaluation criteria​

Instructions

Insert success criteria for each test case of the formative evaluation and for results coming from the evaluation questionnaire.

Sampling considerations​

Instructions

Provide information about the sample size and justification for the choice.

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
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T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
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T-012-008 Formative evaluation report_YYYY_nnn
  • Purpose
  • Responsibilities
    • JD-003
    • JD-005
    • JD-004
  • Terms and Definitions
  • General information
  • Inputs
  • Outputs
  • Formative evaluation plan
    • Purpose
    • Characterization of the medical device
    • Use specification
      • Target user group
      • User profile
      • Use environment
    • Identification of the elements of the user interface
    • Methodology
    • Scenarios
    • Evaluation questionnaire
    • Evaluation criteria
    • Sampling considerations
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.)