Software in Medical Devices, by MD101 Consulting

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Templates SAD and SDD updated

Here is an update of System Architecture Description template and Software Detailed Design template.

I modified the sections in System Architecture Description template to be more specific about SOUP. It lacked a few paragraphs dedicated to SOUPs. It still contains entries compliant with IEC 62304 and section 14 of IEC 60601-1. It should be used to describe the architecture of hardware and software.

I modified as well the Software Detailed Description template document. I added some more comments to make it more usable in various situations.

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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