Software in Medical Devices

Template!
Here is a new template: the all-in-one template for software development process.
It is made for simple software development project where everything can be put in only one document. Especially, there is room for only one verification phase in the template. this is a deliberate situation. If you plan to have more than a single phase of verification, you should use other templates (link on template repository page below at the end of this post).
It contains simple and reduced parts of:

1. Project management plan,
2. Software Requirements Specifications,
3. System Architecture Document,
4. Software Tests Plan, Description and Report.

It doesn't contain the risk management data. They shall remain in the dedicated templates: Risk management plan and Risk analysis report.

More templates on my templates repository page.

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.

Hello,

Back on my blog after a few days off. I wrote in my post about classes of software that I would release a template on user guide. Here it is!

At last, here is the Risk Management Plan Template.

The risk management plan was missing in my list of templates. Error repaired! It is tailor made for software medical devices. So you'll find some stuff specific to software, with references to IEC/TR 80002-1 and IEC 62304.

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.

In Software Test Plan, Software Test Description and Software Test Report I gathered all information about the organization of tests, the traceability with SRS requirements, the description and results of tests.

The Version Description Document is about the description of a delivery of software and hardware. If contains the mandatory information to identify a software version, its dependencies and how it is generated.

This template is the last of my first series of templates. You have all you need to document a software development project of middle importance for a medical device.

However the Project Management Plan template is made for simple projects. For a project with more complexity, you need to pay more attention to software configuration and software development.

The next two templates will be the software configuration management plan and the software development plan. They will contain more information on these subjects than what you find in the project management plan.
Later on, I will add a risk management plan to the templates. Then, the series of management templates will be complete.

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.

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.

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.

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!