Formative evaluation protocol template

Formative Evaluation Protocol Template (IEC 62366-1, Medical Device)

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This template will provide you with a framework to complete your formative evaluation test protocol.


Why it is useful

The formative evaluation test protocol is part of the documentation which is recommended by IEC 62366-1:2015 + AMD:2020. Formative evaluation can be virtually any kind of human-centered assessment of the interface of a medical device. This template focuses on formative evaluation carried out using testing as the method.

The formative evaluation test protocol template is designed so that you can easily use its structure for your summative evaluation test protocol as well. If you do so, replace all appearances of “formative evaluation” by “summative evaluation”.


How to use it

1. If you are preparing for the first formative evaluation for a specific product, fill out all components of this template.
2. If you run a subsequent (e.g., second) formative evaluation for a specific product, you might have to update specific parts of your former protocol for the first test run. However, this is highly dependent on how comparable your test scenarios, methods and test purposes are.
3. Note that the protocol shall be approved before the first formative evaluation starts. With the approval, no further changes are possible.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.



If you have questions about the template’s content, you may ask questions in the support forum. The support forum is accessible on this link when logged into your Medical Device HQ account.


Need usability engineering training and a course certificate?

We do our best to include instructions and example text needed for our templates. Nevertheless, if you want to learn more about usability engineering in general, the topic is covered in our public training courses: Introduction to Usability Engineering and IEC 62366-1 and Usability Engineering and IEC 62366-1 blended course. Our blended courses combine a self-paced online course first, followed by a live virtual classroom session facilitated by an industry expert.

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