SOUP List Lint (IEC 62304)

Runs the same checker as our npm package on a Node.js runtime that pip installs for you (nodejs-wheel-binaries) - no system Node.js needed. Your files are checked locally.

Reads your SOUP register the way an auditor does: 16 rules over clauses 8.1.2, 5.3.3, 5.3.4, 4.3 and 7.1.3.

Install

soup-list-lint file

Node 18+. The same 16 rules as the VS Code extension, from a terminal or CI.

Free

• Lint one SOUP list, completely: every missing manufacturer, unpinned version, unclassified item and undated anomaly-list evaluation, each on its own line with the clause that asks for it.
• --rules lists every rule

With a licence ($29 once)

• Scan every SOUP list in the workspace at once and export a dated evidence record (Markdown + CSV) to file with the technical documentation.

soup-list-lint --dir ./templates --report html --out report.html

A regulatory consultant reviewing SOUP documentation bills $150-$250 an hour; a 30-item register is a morning of that, at every version bump.

Use from an AI agent (MCP)

Claude Code · Cursor · Windsurf · any MCP client - add to your MCP config:

{ "mcpServers": { "soup-list-lint": { "command": "soup-list-lint", "args": ["--mcp"] } } }

Tools: check_text and check_file (free) · check_dir (licence). The agent gets every finding with the line number.

Use in CI

- name: SOUP List Lint (IEC 62304)
  run: pip install rulestamp-soup-list-lint && soup-list-lint --dir . --ci

The folder sweep, reports and CI mode need one licence — one payment, no subscription. Set READYSTACK_LICENSE=<key> or run --license <key> once.

Get a licence

Install (PyPI)

pip install rulestamp-soup-list-lint
soup-list-lint --help