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IEC 62304 and nRF5 SDK

cxz

Hi,

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't doubt that there is. Nordic delivers with a high level of quality, but some explanation of this would be good, specifically for those of us using the SDK and IEC 62304 for medical devices.

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    Hi,

    The SoftDevice (BLE stack) is developed according to Nordic’s ISO9001 certified Software Design & Firmware release
    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.

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