Software in Medical Devices, by MD101 Consulting

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Template: User Guide


Back on my blog after a few days off. I wrote in my post about classes of software that I would release a template on user guide. Here it is!

After the Usability Specification template, here is the User Guide template.

It contains some sections that you should not have tough about at the first time, like safety precautions and contact information.
It contains also parts that are applicable only to companies which sell hardware and software. Selling hardware brings more risks and constraints, which have impacts on the user guide. The lucky companies which sell software only are not subject to such constraints!

It tried to gather every activities linked to the use of software: installing, using, maintaining and uninstalling. However, it may be split into several documents: user guide, installation manual and maintenance manual. If the user is not the person who installs and maintains the software, you'd better have a separate document for user functions and another one for installation and maintenance functions.

By the way, my next post will be about application of ISO 13485 to software manufacturers.

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, feel 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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