The Usability Evaluation Plan outlines the activities and resources needed for conducting Usability Evaluation for the device.
Mapping Standard Requirements to Document Sections
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 4.2 | Usability Engineering File | (all) |
| 4.3 | Tailoring the Usability Engineering effort | (all) |
1. Relevant Processes
The Usability Engineering and Evaluation activities are defined in the SOP Integrated Software Development.
2. Related Documents
- Hazard-Related Use Scenarios List
- Usability Evaluation Report
3. Roles
| Title | Name(s) |
|---|---|
| Head of Usability | |
| Context / Subject Matter Expert (e.g., physician) |
4. Formative Usability Evaluation
4.1 Methods
Formative Usability Evaluation employs the following methods:
- Presenting mockups or prototypes to subject matter experts: Demonstrating functionality through in-person or remote screen-sharing sessions.
- Feedback sessions with UX/UI experts: Displaying concepts, designs, mockups, or prototypes to internal or external UX/UI experts to gather input on potential usability issues and suggestions for improvements.
- User Tests: Allowing members of the target user group to use the device according to a Usability Evaluation protocol, observing their interactions and documenting any usability challenges. This is similar to Summative Usability Evaluation but conducted on a development version of the device for the purpose of enhancing the final product.
4.2 Planning (Overview)
| Date | Description |
|---|---|
| 01.01.2021 | Formative Evaluation 1 (Details on methods, environment, participants, etc.) |
5. Summative Usability Evaluation
5.1 Method
Summative Usability Evaluation involves conducting User Tests. These tests must adhere to the following requirements:
- The user profile should match that in the Device Description.
- All Hazard-Related Use Scenarios must be addressed by test cases (per IEC 62366, sections 5.7.3 / 5.9).
- Test cases should include sufficient stakeholder requirements and user needs to ensure the product fulfills its intended use (refer to ISO 13485, section 7.3.7).
- At least five participants must be involved.
- The Usability Test Protocol must be completed with descriptions of each use scenario and instructions, also serving as documentation for observations and identified hazards.
Optional requirements include:
- Recording Usability Tests (e.g., via video/audio, either in-person or remote, and screen recordings of phone/desktop).
The outcomes of Summative Usability Evaluation are summarized in the Usability Evaluation Report, which should address:
- Were all tasks in the Usability Test Protocol completed?
- If not, what were the reasons?
- Which Use Errors were observed, and could they potentially lead to Hazardous Situations? – A risk analysis of use errors is included.
5.2 Planning (Setting)
Participants
Setting
Methods and Analysis
Outline whether the tests will be conducted in person or remotely and how the results will be documented (at minimum, a protocol should be used). Recording sessions is optional but recommended.
Additionally, explain the method of data analysis.
5.3 Planning (Overview)
| Date | Description |
|---|---|
| 02.01.2021 | Summative Evaluation 1 (Details on methods, environment, participants, etc.) |