soup-record

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shofiqtest / iec62304-embedded-drivers

IEC 62304 compliance documents for upstream embedded OSS drivers (Zephyr RTOS, Linux kernel IIO). SOUP records, FMEA, SRS, SDS — ready to adapt for your medical device project.

embedded linux-kernel eeg iio spo2 medical-device iec-62304 iso-14971 fmea zephyr-rtos biopotential soup-record

Updated Jun 30, 2026

kernel-medical / kernel-soup-gen

Star

Generate IEC 62304 §8 SOUP records for Linux kernel drivers automatically

embedded linux-kernel safety compliance medical-device iec-62304 iso-14971 medical-devices soup-record

Updated Jul 1, 2026
Python

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