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Friday 8 March 2013
By Mitch on Friday 8 March 2013, 14:09 - Standards
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
Friday 14 December 2012
By Mitch on Friday 14 December 2012, 12:35 - Processes
In my last post, I explained the benefits of static analysis. This software verification method is mainly relevant to find bugs in mission critical software. But it fits the need of bug-free software for less critical software as well.
Static analysis can be seen as an achievement in the implementation of software verification methods. Yet, other methods exists that fit very specific purposes.
Friday 7 December 2012
By Mitch on Friday 7 December 2012, 12:45 - Processes
In my last article, I talked about the most classical methods used to verify software: human testing (driven by test cases or not) and unit tests. I was about to talk about static analysis, that I place at a higher level of complexity in the list of verification methods, but I have to say a bit more about unit tests.
Friday 30 November 2012
By Mitch on Friday 30 November 2012, 12:06 - Processes
Software verification is easy to define: to demonstrate that software works as it was specified (and without bugs!). But there's not a unique way to do it.
Let's see what methods we have in hands to verify software.
Friday 23 November 2012
By Mitch on Friday 23 November 2012, 13:06 - Regulations
The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.
Friday 16 November 2012
By Mitch on Friday 16 November 2012, 12:34 - Processes
Writing about V&V in two previous posts, I had a lot of comments from people on a well-known social network. They made corrections to my view of V&V and brought their own definitions.
Here is an excerpt of their comments.
Friday 2 November 2012
By Mitch on Friday 2 November 2012, 14:11 - Processes
Following the article about software verification, let's see what software validation is.
Friday 26 October 2012
By Mitch on Friday 26 October 2012, 14:09 - Processes
Many people make the confusion between verification and validation. There is no exception for software! I'd even say that the confusion is even worse for standalone software.
Let's see first the definition of verification and validation. I borrowed these definitions from the FDA website:
OK, this remains theoretical. How to do that with software medical devices?
In this article I focus on verification and will focus on validation in the next article: What is software validation.
Monday 30 January 2012
By Mitch on Monday 30 January 2012, 19:25 - Templates
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
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.
