Software in Medical Devices, by MD101 Consulting

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Templates

Templates files for software development of medical devices.

These files are under the creative commons CC-BY-ND license.

Please, read the license before any use. 

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Monday, 30 January 2012

New templates: Software Tests Plan, Software Tests Description and Software Tests Report

In Software-Requirements-Specifications, I put everything you need to deal with technical requirements of your software.

In Software-Detailed-Design, I put everything about the design description of packages and component inside software, their interfaces and their workflows.

In System Architecture Description, I put everything about the description of the whole architecture of system and software.

Now that we have enough templates to describe our software, let's see how to test it. How one can release software without thourougly testing it? Nobody, I think. This is the purpose of these 3 software tests templates.

Note: Test = Verification, I could have called those documents

  • Software Verification Plan,
  • Software Verification Description,
  • Software Verification Report.

The next one will be about delivery. Stay tuned, my list of templates is growing fast!

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 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.

Friday, 20 January 2012

Template: System Architecture Description

In Software-Requirements-Specifications, I put everything you need to deal with technical requirements of your software.

In Software-Detailed-Design I put everything about the design description of packages and component inside software, their interfaces and their workflows.

The template about software architecture was missing. Here is the System Architecture Description document! It contains entries compliant with IEC 62304 and section 14 of IEC 60601-1. It should be used to describe the architecture of hardware and software.

The next one will be about software tests. Stay tuned, my list of templates is growing fast!

Please, feel 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.

Tuesday, 10 January 2012

Template: Software Design Description

In Software-Requirements-Specifications, I put everything you need to deal with technical requirements of your software.

The next template I want to share with you is the one about detailed design. The Software Detailed Design template deals with the design description of packages and component inside software, their interfaces and their workflows. It contains entries compliant with IEC 62304. It should be used to describe the internals of software, from components, down to classes or procedures.

The next one will be about the software architecture. Stay tuned, my list of templates is growing fast!

Please, feel 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.

Monday, 28 November 2011

Template: Risks Analysis Report

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.

Friday, 11 November 2011

Template: Project Management Plan

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.

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!

Continue reading...

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 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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