Software in Medical Devices, by MD101 Consulting

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Template SRS updated

Here is an update of Software Requirements Specifications template.

Software Requirements Specifications template is the main document to fill with technical requirements of your software. It contains entries compliant with IEC 62304, IEC 62366 and ISO 14971.

New regulations like Unique Device Identification (UDI) will have an impact on software design. I updated the template with a new section on software requirements coming from these regulations.

Remark: for backward compatibility, the 2012 version of this template can still be downloaded from this article.

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.


1. On Thursday, 7 March 2019, 04:08 by Vijay


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