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Friday 31 May 2013
By Mitch on Friday 31 May 2013, 15:06 - Standards
We saw in the first article of this series, what is a SOUP and what is not a SOUP, according to IEC 62304.
Then we continued in the second article by having a look at OS's and drivers.
Let's now see how to deal with runtimes.
Friday 24 May 2013
By Mitch on Friday 24 May 2013, 14:03 - Standards
We've seen in last article, what is a SOUP and what is not a SOUP, according to IEC 62304.
We've also seen that a lot of 3rd party software are SOUPs, to begin with OS, drivers, runtimes, Just-In-Time (JIT) compilers and frameworks.
How to deal with those to be compliant with IEC 62304?
Monday 21 January 2013
By Mitch on Monday 21 January 2013, 15:34 - Standards
In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.
Friday 11 January 2013
By Mitch on Friday 11 January 2013, 14:08 - Standards
IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?
Friday 28 September 2012
By Mitch on Friday 28 September 2012, 12:10 - Misc
In two previous articles, I talked about the differences of bugs, software failures, and risks.
I left the discussion unfinished about the probability of occurence of a software failure or a defect.
I think that assessing the probability of occurence of a software failure is a hot subject. I've already seen many contradictory comments on this subject. It's also a hot subject for software manufacturers that are not well used to risk assessment.
Friday 14 September 2012
By Mitch on Friday 14 September 2012, 12:06 - Misc
In my previous post about Bugs, Software Risks and Software Failures, I explained the concepts of bugs, defects or anomalies, and the concept of software failure.
Let's continue now with Risks.
Friday 7 September 2012
By Mitch on Friday 7 September 2012, 18:10 - Misc
A bug can lead to a software failure.
Having bugs is a risk.
Having a software failure is a risk.
A software failure is not necessarily a bug!
Do you follow me?
If not, let me give you some more explanations.