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Friday 4 September 2020
By Mitch on Friday 4 September 2020, 14:34 - Regulations
The FDA published in July the final version of the Guidance on Multiple Function Device Products. Despite the absence of the word "software" in the title, it addresses at first software medical devices. It also addresses hardware devices, but we will focus on software in this post.
Friday 27 June 2014
By Mitch on Friday 27 June 2014, 11:10 - Standards
Continuing with ISO/DIS 13485:2014, after having made an overview of software-related changes in the last article, let's focus on the new clause #4.1.6.
Friday 28 March 2014
By Mitch on Friday 28 March 2014, 12:50 - Processes
We saw in the last post how to validate a software development tool. But we saw also that validating a compiler this way is not a satisfactory task.
Then: Why, when, and how to validate a compiler?
Friday 28 February 2014
By Mitch on Friday 28 February 2014, 13:49 - Processes
If you've haven't heard about Apple's security flaw registered as CVE-2014-1266 on apple website, you probably were on planet Mars.
Basically, it was unsafe to use https connections. I couldn't help but write an article about this!
Components dealing with secured connections are abolutely critical. Applying rigorous development process is the best chance to avoid any trouble with these components.
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 the 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!
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