Software in Medical Devices, by MD101 Consulting

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Wednesday 9 November 2011

Template: Design consolidation document

This template is useful for people addicted to extreme programming: Design consolidation document.

Reviewers are not confortable with iterative processes. When you look at recognized standards for soft development, like IEC 62304, you can see that they are stuck to the waterfall process. Extreme programming isn't their cup of tea!

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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.

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