Support for IEC 62304 compliance using nRF Connect SDK

[bdub94]

We’re developing a medical device under IEC 62304 and plan to use nRF Connect SDK. Does Nordic offer any documentation or process descriptions to support IEC 62304 compliance (e.g., development lifecycle, version control, or verification details)?

[Susheel Nuguru]

The nRF Connect SDK that bundles Zephyr and Nordic’s libraries, is not EC 62304-certified as far as I know. You have to treat it as Software of Unknown Provenance (SOUP) in your IEC 62304 process. So, you can use the SDK in medical devices, but it will be your responsibility for managing its lifecycle, doing the verification work, and handling all the documentation.

We do have a lot of helpful documents that you might use to make this process simpler.

• We do maintain ISO 9001 and ISO 27001 certifications. These documents can be included in your supplier approval and quality documentation
• he SDK toolchain includes support for generating a complete SBOM for the exact software build you ship.
• You can find this document helpful aswell ISO 9001:2015