Software in Medical Devices, a blog by MD101 Consulting

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Friday 27 June 2014

ISO/DIS 13485:2014 strengthens requirements about software - Part 2

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.

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Friday 28 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 2: compilers

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?

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Friday 28 February 2014

Goto Fail

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.

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Friday 31 May 2013

Got SOUP? - Part 3 - Runtimes, Frameworks

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.

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Friday 24 May 2013

Got SOUP? - Part 2 - OS, Drivers, Runtimes

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?

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Monday 21 January 2013

Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices?

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.

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Friday 11 January 2013

What is a Software Unit?

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?

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Friday 28 September 2012

Probability of occurence of a software failure

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.

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Friday 14 September 2012

How to differenciate Bugs, Software Risks and Software Failures - Part 2

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.

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Friday 7 September 2012

How to differenciate Bugs, Software Risks and Software Failures - Part 1

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.

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