fact_check

Usability Evaluation Protocol

Use this Usability Evaluation Protocol template to systematically plan and document your medical device user interface summative usability testing, focusing on critical and hazard-related use scenarios as required by IEC 62366-1:2015. This protocol ensures that all necessary user tests are outlined, tracked, and evaluated, supporting your risk management and design verification processes. Complete this document before conducting usability testing to demonstrate compliance and capture essential data for your Usability Evaluation Report.
Generate ->

Usability Evaluation Protocol

ID: Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium.

1. Scope

The purpose of the usability evaluation protocol is to perform a summative evaluation of user interface of the product according to the Usability Evaluation Plan. The usability evaluation protocol will include user tests that will be executed and the results will be captured within the Usability Evaluation Report. The user tests will cover all hazard-related use scenarios identified during the risk assessment process.

2. User Information

2.1 Use Specification

Information related to the use specification can be found in the Intended Use document.

2.2 Intended Users

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vivamus eget facilisis nibh.

2.3 Intended Use Environment

Quisque dictum, odio et dictum pretium, ex enim cursus orci, ac interdum lorem urna in risus.

3. Device Information

3.1 User Interface Description

Nulla facilisi. Pellentesque commodo, enim a rutrum malesuada, sapien massa dictum quam, at dictum urna augue nec dui.

3.2 Training Required for Users

Aliquam erat volutpat. Etiam euismod, lectus ac pretium facilisis, augue elit pretium velit, a dictum velit urna at leo.

3.3 Materials Supplied to Users

Suspendisse potenti. Proin euismod, urna ac cursus placerat, enim urna dictum augue, id malesuada augue orci in libero.

4. Hazard-Related Use Scenarios

Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia curae; In hac habitasse platea dictumst.

4.1 Hazard-Related Use Scenarios Tasks

Morbi sed enim sed dolor feugiat dictum. In euismod, tortor nec pretium cursus, diam erat dictum lacus, at cursus enim urna vitae enim.

5. User Testing

User tests will be performed to capture the performance of the hazard-related use scenario tasks identified in Section 4.1. All critical tasks, if any, will be performed by the users to evaluate the usability of the user interface. Information that will be captured for each user will include:

5.1 User Feedback

Feedback will be gathered from users in the form of questions to be answered following the testing. Questions to gather user feedback can include, but are not limited to, the following to be asked to all users.

  • How would you describe using the application?
  • What, if anything, was difficult about using the application?
  • What, if anything, can be improved about the user interface of the application?
  • What, if anything, did you like about the application?
  • How did using this application compare to using other, similar applications?

5. Impact of User Testing

The following processes are evaluated as to whether they are significantly impacted by the results of the usability testing.

  • Risk management file
  • Software requirements
  • Software and/or user interface design
  • Use specification

The results and impact of user testing will be captured in the Usability Evaluation Report.

Medical Device Certification Made Easy.