https://devzone.nordicsemi.com/f/nordic-q-a/61372/iec-62304-and-nrf5-sdkHi, I know that Nordic has the ISO 9000 certification, but it seems to make no mention of software on the certificate. Could someone explain if there is some QA methodology behind the nRF SDK? I don&#39;t doubt that there is. Nordic delivers with a highen-USTelligent Community 13Thu, 14 May 2020 12:06:39 GMThttps://devzone.nordicsemi.com/thread/249947?ContentTypeID=1Thu, 14 May 2020 12:06:39 GMT137ad170-7792-4731-bb38-c0d22fbe4515:2dac5677-47a1-4a45-acd3-b8f157090cfeEinar Thorsrud<p>Hi,</p> <p>The SoftDevice (BLE stack) is&nbsp;developed according to Nordic’s ISO9001 certified Software Design &amp; Firmware release<br />process, and defined on the highest level of criticality. (To our knowledge, the SoftDevice has always been referred to as Source Code of Unknown Provenance (SOUP) by customers seeking FDA approval). The SDK is also extensively tested, but less so than the SoftDevice. Extensive testing and qualification is up to you as it is available in source code.</p><div style="clear:both;"></div>