Freertos + softdevice for medical device IEC62304

RE: Freertos + softdevice for medical device IEC62304

aburns135 — Thu, 20 Feb 2025 14:13:01 GMT

thanks Einar, contacted sales....seems some safety certification is on the horizon so i pinged the zephyr comminity in parallel about this www.linkedin.com/.../the-zephyr-project_zephyrrtos-news-opensource-activity-7290749146381090817-Gq_8

RE: Freertos + softdevice for medical device IEC62304

Einar Thorsrud — Thu, 20 Feb 2025 13:57:26 GMT

Hi,

There is no IEC62304 certification for Zephyr or the nRF Connect SDK. If you have such requiermetns I suggest you contact your local Nordic sales representative.

RE: Freertos + softdevice for medical device IEC62304

aburns135 — Thu, 20 Feb 2025 13:52:23 GMT

Hi,

Some customers making new medical devices are asking (some BLE nRF54x, some nRF9151 and some both BLE + Cell)

Has Zephyr RTOS got IEC62304 yet ? either a free or commercial version ? like what safertos and threadx have below

http://threadxalliance.org/subscription/safety-certifications/

www.freertos.org/.../SafeRTOS

RE: Freertos + softdevice for medical device IEC62304

geoffF — Tue, 17 Oct 2023 03:13:43 GMT

Fair enough. Hopefully a Nordic person can comment on its status but my impression was it is in maintenance only phase now but could be wrong.

RE: Freertos + softdevice for medical device IEC62304

pavanshet — Tue, 17 Oct 2023 03:10:58 GMT

Thank you for the quick response. At this stage we would like to stick with old NRF sdk.

RE: Freertos + softdevice for medical device IEC62304

geoffF — Tue, 17 Oct 2023 03:07:23 GMT

You mean the nrfxlib parts of the Connect SDK? There are no "softdevices" perse in the new SDK - I don't think anything is precompiled like it was under the old nRF5 SDK. Though under the hood the Zephyr BLE implementation is ultimatly driven by Nordics nrfxlib but you have full access to the source code. This posts first comment might explain better, from Nordic when ConnectSDK first came out:
SoftDevice version included in nRF Connect SDK

RE: Freertos + softdevice for medical device IEC62304

pavanshet — Tue, 17 Oct 2023 02:54:00 GMT

How did you handle use of softdevice in the project ?

RE: Freertos + softdevice for medical device IEC62304

hmolesworth — Tue, 17 Oct 2023 02:47:18 GMT

You might consider Safety_Critical_Certified/SafeRTOS

RE: Freertos + softdevice for medical device IEC62304

geoffF — Tue, 17 Oct 2023 02:12:20 GMT

A Nordic member will confirm but I don't think FreeRTOS+Softdevice would be recommended for new projects. I have used it's replacement, nRF Connect SDK (Zephyr based) for a 62304 project and found it to be well supported. It is well documented and Noridc publish a large amount of unit testing inside the SDK itself - which I believe they maintain themselves as a kind of fork of Zephyr. You will always have to justify and risk assess every piece of SOUP in a 62304 project, establish procedures to monitor updates for critical fixes etc, but for their part Nordic do make a lot of information available, at least in my experience.