On the bundled sample: 14 findings (11 errors, 3 warnings) in 1 file from 16 rules, including “^3.45” and “latest” as versions, a “TBD” manufacturer and an anomaly list never evaluated.

Who it’s for
For medical device software teams who keep their SOUP list in Markdown in git and face an IEC 62304 audit or notified body review.

What breaks, and when
A placeholder in the technical file is a missing record. An anomaly-list evaluation older than 365 days means new anomalies published since then have not been judged.

What you get
• SKILL.md, an offline Node scanner and the 16-rule table
• file:line, SOUP item and IEC 62304 clause per finding

See it first
The real output of the bundled example is on getreadystack.com/skills/iec-62304-soup-list-check/ — free, no sign-up, so you see what it finds before you pay.

Install in 30 seconds
Unzip into ~/.claude/skills/, then ask Claude Code: “We have an IEC 62304 audit coming. Is the SOUP list in our docs folder complete? Don’t edit anything yet.”. Needs Node 16+.

What it does not do
Reads *.md only and checks records are present, not true.

FAQ
Q: How is this different from asking Claude without the skill?
A: The skill carries a dated rule table and a scanner that reads every file, so Claude quotes the exact date and line instead of guessing from memory.
Q: How do I get the files?
A: In your Whop library after paying: the lesson “iec-62304-soup-list-check.zip”.