Software in Medical Devices, by MD101 Consulting

Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website, posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304.

To continue with the last article about FDIS IEC 62366-1 standard, let's see now the consequences of this standard on software design.

Continuing with the schedule of the ISO TC 210 committee, let's see when the next versions of IEC 62304 and IEC 62366 will be released.

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.

In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.
Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.

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.

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.

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?

Want to see latest news about IEC 62304 2nd Edition?
Have a look at this thread on Elsmar Cove Forum: Update on IEC 62304 revision.
This thread contains an interesting discussion about the topics that are being amended in IEC 62304 by IEC working group:

• Safety classes,
• SOUP,
• Legacy software.

Enjoy.

Note: for those who don't know Elsmar Cove forum, it's probably the best forum about quality management and standards.

EDIT: elsmar cove forums is dead, see RIP elsmar cove.

In the previous post, we've seen when it's mandatory to be compliant both with IEC 60601-1 and IEC 62304, and when IEC 60601-1 alone is enough.

But some manufacturers don't apply IEC 60601-1, mainly because their devices are not in contact with the patient or cannot be qualified are medical devices. We find in these categories in-vitro diagnosis instruments and laboratory instruments.
These instruments usually fall in the scope of IEC 61010-1. Let's see now the relationship between IEC 61010-1 and IEC 62304.