Software in Medical Devices, by MD101 Consulting

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Monday, 28 November 2011

Template: Risks Analysis Report

By Mitch on Monday, 28 November 2011, 19:25 - Templates

Templates section wouldn't be a templates section without something about risk analysis. Error repaired!

Here is the Risk Analysis Report Template. It contains sections compliant with IEC 62304, IEC 62366 and ISO 14971. It is best used in conjunction with the SRS template.

Please, fell free to give me feedback on my e-mail contact@cm-dm.com

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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Friday, 11 November 2011

Template: Project Management Plan

By Mitch on Friday, 11 November 2011, 15:30 - Templates

Here is the Project Management Plan Template.

This template doesn't contain anything technical. Has it something to do with software development? Yes, it has. It contains all the answers to questions like: Who, What, Where, When, How, Why and How much? You can do all the technical stuff you want, but without a minimum of organisation, your software will never be certified. This template deals with sections of IEC 62304 about project organisation. Use it to answer to those requirements of the standard.

Please, fell free to give me feedback on my e-mail contact@cm-dm.com

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.

no comments

Wednesday, 9 November 2011

Template: Design consolidation document

By Mitch on Wednesday, 9 November 2011, 22:58 - Templates

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!

Continue reading...

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Template: Software Requirements Specifications

By Mitch on Wednesday, 9 November 2011, 22:41 - Templates

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 contact@cm-dm.com

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.

4 comments

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