Software risk management under ISO 14971: linking software hazards to system risks

ISO 14971 is a product-level standard, but most software teams treat risk management as a software-only exercise. The result is a risk file that satisfies the standard on paper while missing the connections that auditors and reviewers actually care about: how software failure modes link to system-level harms, and how risk controls at the software level trace back to the overall risk management plan.

In this session from the Greenlight Guru Software Enabled Devices Virtual Summit, Naomi Schwartz walks through how to structure software risk management in a way that integrates properly with ISO 14971 at the system level.

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