Freertos + softdevice for medical device IEC62304

[pavanshet]

We are planning to use NRF52840 for a medical device would like to know from Nordic or anyone from the forum about the verification/validation of SOUP (Software of unknown provenance) in this case Freertos and BLE stack (Softdevice). Any guideline would be appreciated. We are designing patient vital monitoring device.

[geoffF]

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.

[pavanshet]

How did you handle use of softdevice in the project ?

[geoffF]

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

[pavanshet]

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

[geoffF]

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.