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QMSQMS
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-012-008 Formative evaluation report_YYYY_nnn

T-012-008 Formative evaluation report_YYYY_nnn

Characterization of the medical device​

Software version​

Introduction

Insert the software version tested during the formative evaluation.

Intended medical indication​

Introduction

Insert the intended use and intended purpose of the device.

Intended patient population​

Introduction

Insert the intended patient population.

Intended part of the body or type of tissue applied to or interacted with​

Introduction

List all applicable part of the body.

Intended user profile​

Introduction

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

Intended use environment​

Introduction

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).

Operating principle​

Introduction

Insert a brief description of the operating principle of the device.

Presence of user interface of unknown provenance​

Introduction

List any user interface of unknown provenance integrated in the device.

User interface characteristics related to safety and potential use errors​

Introduction

List and describe the elements of the user interface and any potential use errors that can occur.

Method for formative evaluation​

Introduction

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. This section can be copied and pasted from R-TF-012-007 Formative evaluation plan.

Testing environment​

Introduction

Describe the environment where the formative evaluation test was executed.

About the testers​

Introduction

Provide information about the testers in terms of experience, knowledge, background.

Requirements related to usability​

Introduction

List the requirements that are related to usability.

Formative evaluation results​

Context​

Introduction

Provide information about number of participants, dates of the formative evaluation test, device version, IFU version.

Summary of results and insights​

Introduction

Insert a summary of the results of the formative evaluation test and results of the feedback obtained by means of the evaluation questionnaire, and provide a comparison with the success criteria established in R-TF-012-007 Formative evaluation plan.

Conclusions​

Introduction

Insert final conclusions about the formative evaluation test according to the actual results.

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-012-007 Formative evaluation plan_YYYY_nnn
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T-012-009 Validation and testing of machine learning models_YYYY_nnn
  • Characterization of the medical device
    • Software version
    • Intended medical indication
    • Intended patient population
    • Intended part of the body or type of tissue applied to or interacted with
    • Intended user profile
    • Intended use environment
    • Operating principle
  • Presence of user interface of unknown provenance
  • User interface characteristics related to safety and potential use errors
  • Method for formative evaluation
  • Testing environment
  • About the testers
  • Requirements related to usability
  • Formative evaluation results
    • Context
    • Summary of results and insights
    • Conclusions
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.)