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

[Heidi-Irene Harvey Sollie]

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