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Updated September 30, 2021

Template: Usability Evaluation Plan

Dr. Oliver Eidel
IEC 62366

This is a free template, provided by OpenRegulatory.

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.
Beginning of 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 analyze 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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End of template


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