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Monday, 20 February 2023
By Mitch on Monday, 20 February 2023, 13:56 - Standards
These three concepts come from IEC 62443 and were adopted in IEC 80001-5-1. SOUP isn't present in IEC 81001-5-1.
What are the differences between SOUP and Maintained software, Supported software, and Required software?
Monday, 8 November 2021
By Mitch on Monday, 8 November 2021, 13:56 - Regulations
That is the question.
MD manufacturers are pressed by end-users to implement changes. Especially SaMD, where the users are used to receiving new versions weekly or monthly. Thus, Class I MDD SaMD manufacturers are pressed to find a way to qualify their software changes as non-substantial according to the MDCG 2020-3. Otherwise, they can't deliver new versions to their end-users, blocked by the deadly MDR rule 11 and its class IIa trap.
Friday, 26 March 2021
By Mitch on Friday, 26 March 2021, 13:38 - Misc
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.
Friday, 14 March 2014
By Mitch on Friday, 14 March 2014, 13:26 - Processes
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.
Friday, 11 October 2013
By Mitch on Friday, 11 October 2013, 14:08 - Processes
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!
Friday, 5 July 2013
By Mitch on Friday, 5 July 2013, 14:00 - Standards
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
By Mitch on Friday, 28 June 2013, 14:28 - Standards
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.
Friday, 14 June 2013
By Mitch on Friday, 14 June 2013, 13:43 - Standards
After having discussed about open-source software in the last post, we continue today this series about SOUP with the case of standalone software.
Friday, 7 June 2013
By Mitch on Friday, 7 June 2013, 13:52 - Standards
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.
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?
Friday, 17 May 2013
By Mitch on Friday, 17 May 2013, 14:21 - Standards
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?
