Pre-validated Yocto BSP, IEC 62304 §8 SOUP records, and ISO 14971 FMEA for Linux-based medical devices — written by an upstream Linux kernel contributor.
Medical device companies building on Linux face the same bottleneck: SOUP records for every kernel driver used in the device. Regulatory consultants charge €50k+ and still don't understand the kernel source.
Manually documenting kernel drivers for IEC 62304 §8 takes months per product. Each kernel version bump restarts the process.
Traditional regulatory consultants know the standard but cannot read kernel source. They ask your engineers to document everything manually.
Every LTS kernel upgrade requires re-validating SOUP records. Without automation, teams avoid upgrades — leaving security vulnerabilities unpatched.
Deliverables are written by someone with active upstream kernel contributions and IEC 62304 medical device experience — not a generic regulatory consultant.
Auto-generate IEC 62304 §8 SOUP records for any Linux kernel driver directly from the source tree. Used to produce all SOUP deliverables in the packages above.
MODULE_* macros · copyright holders · kernel version · official maintainers · Kconfig dependencies · commit history · CVE search links
SOUP records are only credible if the author understands what the driver actually does. Regulatory consultants don't read kernel C. This service does both.
Describe your hardware platform, target kernel version, and regulatory class.
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