Software in Medical Devices, by MD101 Consulting

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Friday 26 March 2021

When Web meets SOUP

The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.
Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.

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Friday 14 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 1

Validating the compiler used in software development is a recurring issue. To what extent a compiler should be validated, when, how and why?
In the same vein, we can extend the question of validation to all tools used in the software development environment: integrated development environment, configuration management tools, compiler (and linker), automated test tools.

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Friday 11 October 2013

How to validate a software medical device running on web browsers?

Your company develops medical web apps (HTML/JS, HTML5 or any other client-side technology) and your customers would like them to run on every web browser.

Web browsers are SOUP, according to IEC 62304. In case of Chrome and Firefox there are dozens of versions...

Does it mean that software has to be tested - and documented - with every single browser and every single version of the browser?
That's a nightmare!

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Friday 5 July 2013

Got SOUP? - Further Reading

Further reading to complete this long series about SOUP:
You can have a look at this excellent article about OTS/SOUP validation strategies.

Next week, we'll see Unique Device Identification (UDI) for software.

Friday 28 June 2013

Got SOUP? - Part 6 - FDA Guidance and Conclusion

This is today the last article of this series about SOUP.
SOUP is a concept that we find elsewhere than in the IEC 62304 standard. Namely in the FDA guidances.

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Friday 14 June 2013

Got SOUP? - Part 5 - Standalone software

After having discussed about open-source software in the last post, we continue today this series about SOUP with the case of standalone software.

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Friday 7 June 2013

Got SOUP? - Part 4 - Open-Source Software

After having discussed about frameworks and runtimes in the last article, we continue today this series about SOUP with the case of open-source software.

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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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Friday 17 May 2013

Got SOUP? - Part 1 - Because every good software starts with SOUP

No need to reinvent the wheel when developing software. Everybody uses software made by 3rd parties, to begin with the operating system and general purpose libraries.
IEC 62304 has specific requirements about 3rd party software. What are these requirements and how do they affect software development and maintenance?

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