Software in Medical Devices, by MD101 Consulting

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Template: Usability Specification Document

After the Risk Managment Plan template, here is the Usability Specification Document.

The Usability Specification Document is your companion during the phases where you define the graphical user interface and ergonomics of your software.

It contains two main chapters:

  • One you fill before the specifications phase, when you initiate the design of the grahical user interface
  • One you fill during the specifications phase, when you go deeper into details.

This document gives inputs to the risk management process, hence hazardous situations found before specifications shall be mitigated. So it is strongly linked to the Risk Analysis Report.
This document is also liked to the Software Requirements Specifications, hence ergonomic requirements are described first in this document and described with more details in the SRS. Every requirement found in the SRS shall be tested in the Software Tests Plan. So every ergonomics requirement will be tested during the tests phases, which is good.

Warning, this document is not a validation plan. Validation of your software shall be described in the project management plan or software development plan.

Validating the user interface of a software is a process strongly linked to other processes of software developement and risk analysis:

  • Draft user interface and risk analysis are conducted before specifications, hazardous situations include those related to user interface,
  • Specification of user interface is done during specifications, software requirements mitigating risks include those related to user interface,
  • During conception and coding, an update software requirements, user interface requirements and risk analysis may happen,
  • Verification tests include those of user interfaces and tests of requirements mitigating risks include those of requirements mitigating risks linked to user interface,
  • Validation tests or reviews, done with end-users or beta testers (call them as you want) include the review of user interfaces and scenarios.

By the way, I'll continue my series of posts about inflation of medical devices in the next post.

Stay tuned, my list of templates is growing fast!

I gather all my templates on the templates page. You'll find them all there.

Please, fell free to give me feedback on my e-mail

I share this template with the conditions of CC-BY-NC-ND license.

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

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