Using NRF9160 in FDA Class 2 Medical Device

[peter_100P]

Given that Zephyr RTOS is not certified for use on Medical Devices, is there any plan to support operating systems with FDA 510(k), IEC 62304, IEC 60601 certifications?

The devices we're designing are intended for remote patient monitoring, which is expected to be a multibillion dollar market over the next few years in the US alone. I love the design of the module, but without a path to a 510(k) I can't do anything else with it.

Thanks,

Peter

[Keith Brafford]

You could check out ThreadX from ExpressLogic.  They have lots of certifications (the ones that are relevant for embedded software).  They support the ARM Cortex-M (which should cover the M4 and M33).  And if there is anything particularly un-certifiable about Nordic's SoftDevice structure, they will surely be able to explain:

https://rtos.com/solutions/threadx/certification/

That said, you can design FDA approved medical devices that use off the shelf software like RTOSes.  They call it SOUP (software of unknown pedigree), and it just factors in to how much testing and documentation you have to add to make up for the fact that you are leveraging software you didn't write:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices

[peter_100P]

Thanks for the link. SOUP is exactly what I'm trying to avoid here because time to market for us is worth a lot more than the cost of a certified RTOS.

[Keith Brafford]

If you are willing to pay for a commercial OS (instead of using a free one), then ThreadX is totally the way to go. Good luck with your search!