Claude Code skills · updated 2026-10-03

IEC 62304 SOUP list skill for Claude Code — missing records, unpinned versions

14 findings in one sample SOUP list, each with the IEC 62304 clause

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.

Get it on Whop - $12 onceGet it on Gumroad

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 it printed on the bundled example

== SOUP List Lint — 14 findings (11 errors, 3 warnings) in 1 file · 16 rules
  WARN  soup-sample.md:5  [soup_anomaly_date_stale]
        "zlib": anomaly list last evaluated 2024-11-05 — 703 days ago. New anomalies published since then have not been judged.
  ERROR soup-sample.md:6  [soup_version_not_pinned]
        "SQLite": version "^3.45" is a range or a pointer, not a unique designator. Record the exact version that went into the build.
  ERROR soup-sample.md:7  [soup_placeholder_value]
        "libcurl": manufacturer still says "TBD". A placeholder in the technical file is a missing record.
  ERROR soup-sample.md:8  [soup_anomaly_review_missing]
        "OpenSSL": the published anomaly list was not evaluated. 7.1.3 asks you to read the supplier's known-bug list and judge whether any anomaly can contribute to a hazardous situation.

What you get

• SKILL.md, an offline Node scanner and the 16-rule table
• file:line, SOUP item and IEC 62304 clause per finding
• Proposed row fixes, applied only after you agree
• CI: the scan exits 1 on any error

Install

Unzip into ~/.claude/skills/ (all projects) or your-repo/.claude/skills/ (one repo), 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+.

unzip iec-62304-soup-list-check.zip -d ~/.claude/skills/

Ask Claude

“We have an IEC 62304 audit coming. Is the SOUP list in our docs folder complete? Don't edit anything yet.”

What it does not do

Reads *.md only and checks records are present, not true. It does not set your safety class.

FAQ

What is a Claude Code skill?

A folder with a SKILL.md and scripts that Claude Code loads when your request matches it. You ask in plain words and Claude runs the scanner the skill carries.

How is this different from asking Claude without the skill?

The skill carries a dated rule table and a scanner that reads every file, so Claude quotes the exact date and line instead of answering from memory.

Does it send my code anywhere?

Reads *.md only and checks records are present, not true. It does not set your safety class.

How do I install it?

Unzip into ~/.claude/skills/ (all projects) or your-repo/.claude/skills/ (one repo), 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 do I get when I buy?

The zip. On Whop it is in your library as a download lesson with the zip attached; on Gumroad it is the product file.