OpenRegulatory Template

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

IEC 62366-1:2015 Section Title Document Section
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.

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 is performed with the following methods:

4.2 Planning (Overview)

Date Description
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 following requirements are optional:

Results of Summative Usability Evaluation are summarized in the Usability Evaluation Report, most importantly:

5.2 Planning (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)

Date Description
02.01.2021 Summative Evaluation 1
(Description of methods incl. environment, participants etc.)

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