Software in Medical Devices, by MD101 Consulting

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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!

The only way to do it is to have documents, which consolidate the results of your iterative process. The consolidated document will be submitted to the FDA in appendix 16 of 510k tech file, for example.

Look at the template attached, it may give you some ideas. I already used that one: at each iteration, you fill the document with new requirements, you modify the conception and you test the result, and you increase the document version number. There is also a chapter on risk management. As the development process is iterative, so is the risk management process.

The document shall be signed by a project manager and if possible by a user/customer at each iteration. The signatures materialize the agreement about the content of the iteration. From design point of view, a final test phase shall be realised to ensure that every requirement was tested and passed. Especially for requirements, which mitigate risks. Compared with 62304 standard, this is the verification. After this final tests, a "end of design" review shall be organized. Iterative doc + final test doc + risk management doc are reviewed and approved during this meeting.

Please, fell free to give me feedback on my e-mail

I share this template with the conditions of CC-BY-NC-ND license.

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

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