Software in Medical Devices, by MD101 Consulting

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Template: Software Requirements Specifications

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

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.


1. On Friday, 30 March 2012, 22:30 by chambes

I have learned a lot from your blog - thanks!

I am getting a 404 error when trying to download this SRS template. Could you point me to the right location?

2. On Sunday, 1 April 2012, 11:57 by Mitch

404 error fixed.


3. On Monday, 25 June 2012, 20:04 by Silviu

Your blog has helped me a lot! Thanks. Keep up the good work.

I have a question though. In your SRS template you have a traceability matrix of "SRS requirements" to "functional requirements". What are those functional requirements and In which document should they be described? Do you have a template for them as well?

4. On Tuesday, 26 June 2012, 11:07 by Mitch

Hi Silviu,

Usually the first requirements you get are those from users. Users don't have software programming skills and formulate very high-level requirements, like "I want to display ultrasound images on a tablet". That's why they're called user requirements. They are collected in a document like a statement of work or in a list of use cases. User requirements (like use cases) are not written in a very formal way and don't require a template to collect them.

Then the user requirements are translated into software requirements in a SRS. The traceability between user requirements and software requirements ensure that soft reqs match the objectives of user reqs.

If you don't have such requirements, no problem. This is usually the case for "small" software, where user requirements are directly put in the SRS. Just add "not applicable" in the chapter. And explain why.

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