Using NRF9160 in FDA Class 2 Medical Device

RE: Using NRF9160 in FDA Class 2 Medical Device

Heidi — Mon, 14 Oct 2019 11:37:52 GMT

Hi! For information on future plans, please contact your regional sales manager. If you send me a private message with your location, I can provide the contact information.

Best regards,

Heidi

RE: Using NRF9160 in FDA Class 2 Medical Device

Keith Brafford — Fri, 11 Oct 2019 05:09:51 GMT

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!

RE: Using NRF9160 in FDA Class 2 Medical Device

peter_100P — Fri, 11 Oct 2019 04:55:17 GMT

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.

RE: Using NRF9160 in FDA Class 2 Medical Device

Keith Brafford — Fri, 11 Oct 2019 04:07:56 GMT

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