Software in Medical Devices, a blog by MD101 Consulting

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Friday 18 October 2013

Template: new Software Configuration Management Plan

A new Software Configuration Management Plan (SCMP) Template, more adapted to agile methods.

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Friday 4 October 2013

Template: Risk Matrix Calculator

Risk matrixes are a useful way to show graphically the ranges in which risks are acceptable, tolerable and unacceptable. Here is an excel sheet that automates the computation of ranges.

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Friday 20 September 2013

Templates Risk Management Plan and Risk Analysis Report updated

Here is an update of Risk Management Plan and Risk Analysis Report templates.

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Friday 13 September 2013

Templates STP - STD and STR updated

Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.

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Friday 6 September 2013

Templates SAD and SDD updated

Here is an update of System Architecture Description template and Software Detailed Design template.

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Friday 30 August 2013

Template SRS updated

Here is an update of Software Requirements Specifications template.

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Friday 17 August 2012

Three templates

I've already posted a long list of templates on this blog. You can find them on the templates repository page.
There are templates for big projects, with one or more templates for every phase of a software development project. And there is the all-in-one template for very simple projects. This list lacks templates for simple projects that deserve more than a single document.
Here are the three templates:

  1. Software Development Management
  2. Software Specifications and Conception
  3. Software Verification and Tests

The advantage of this list is to have multiple specification conception and tests phases. The management template is filled at the beginning of the project. The Specification and Conception template is filled and updated each time these artifacts change. And the tests template is filled during each tests phase. They fit simple to middle size projects:

  • Project timeline of 1 year
  • Team of 4 developers
  • Simple architecture (standalone or client-server)

They don'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.



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

Friday 3 August 2012

How to use templates with agile methods?

All templates I have written are listed in my templates repository page. I already explained in that page and some other articles how to use them with waterfall development process.
But their use is not obvious with agile methods. Here are a few explanations.

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Friday 27 July 2012

Template: All-in-one

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.



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

Friday 20 July 2012

Where do these templates come from?

Perhaps some of you who download my templates wonder how I managed to write them or where they come from.
This is a long story. Once upon a time in 1940’s, Bell Labs scientists John Bardeen, Walter Brattain and William Schockley invented the transistor.
Well, huh, not so long!

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Friday 4 May 2012

Template: User Guide

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!

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Friday 23 March 2012

Template: Usability Specification Document

After the Risk Managment Plan template, here is the Usability Specification Document.

The Usability Specification Document is your companion during the phases where you define the graphical user interface and ergonomics of your software.

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Friday 9 March 2012

Template: Risk Management Plan

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.

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Wednesday 29 February 2012

Templates: software development plan and software configuration management plan

Here are the Software Development Plan Template and the Software Configuration Management Plan Template

These templates are technical ones. But they are closely linked to project management hence they contain sections about reponsibilities.

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Friday 17 February 2012

Template: Version Description Document

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.



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

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.

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