Usability Evaluation Plan
The Usability Evaluation Plan describes the Usability Evaluation
activities and their required resources which will be performed for the
device.
Mapping
of Standard Requirements to Document Sections
| 4.2 |
Usability Engineering File |
(all) |
| 4.3 |
Tailoring of the Usability Engineering effort |
(all) |
1. Relevant Processes
Usability Engineering and Evaluation activities are defined in the
SOP Integrated Software Development.
- List of Hazard-Related Use Scenarios
- Usability Evaluation Report
3. Roles
| Head of Usability |
|
| Context / Subject Matter Expert, e.g., physician |
|
4.1 Methods
Formative Usability Evaluation is performed with the following
methods:
- Presentation of mockups or prototypes to subject matter
experts: E.g., by demonstrating the functionality in an
in-person or remote screen sharing session.
- Feedback sessions with UX/UI experts: Showing
concepts, designs, mockups or prototypes to internal or external UX/UI
experts with the goal of gathering feedback on potential usability
problems and improvements.
- User Tests: Letting users of the intended target
user group use the device based on a Usability Evaluation protocol,
observing them and documenting potential Usability problems. This is
essentially the same methods as the Summative Usability Evaluation, with
the only difference being that it’s being done on a development
(non-final, non-release) version of the device with the goal of
gathering knowledge for improving the final device.
4.2 Planning (Overview)
| 01.01.2021 |
Formative Evaluation 1
(Description of methods
incl. environment, participants etc.) |
5 Summative Usability
Evaluation
5.1 Method
Summative Usability Evaluation is conducted by performing User
Tests.
User Tests must comply with the following requirements:
- The user profile is the one specified in the Device
Description.
- All Hazard-Related Use Scenarios must be covered by test cases (see
IEC 62366, para. 5.7.3 / 5.9).
- Sufficient stakeholder requirements / user needs must be covered by
test cases to ensure that the product meets its intended use (see ISO
13485, para. 7.3.7)
- At least five test participants.
- The Usability Test Protocol must be filled out which descriptions of
each use scenario and instructions. It is also used to document the
observations and discovered hazards.
The following requirements are optional:
- Usability Tests are recorded, e.g., video/audio (either in-person or
remotely) and screen recording (of phone / desktop computer)
Results of Summative Usability Evaluation are summarized in the
Usability Evaluation Report, most importantly:
- Could all tasks in the Usability Test Protocol be achieved?
- Which Use Errors occurred and could they lead to Hazardous
Situations? –> Risk analysis of use errors
5.2 Planning (Setting)
Participants
Setting
Methods and Analysis
Describe whether it’s done in person or remotely and how you will
document the results (have a protocol at the minimum), optionally also
record the sessions.
Also, describe how you plan to analyse the data.
5.3 Planning (Overview)
| 02.01.2021 |
Summative Evaluation 1
(Description of methods
incl. environment, participants etc.) |
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