SOUP List Lint (IEC 62304)

It reads the markdown file holding your SOUP register and applies 16 rules from five IEC 62304 clauses. It flags a missing manufacturer or title, a version written as a range instead of the exact build, absent functional or hardware requirements, a missing or invalid safety class, and an anomaly-list evaluation that is absent, undated, future-dated or older than 365 days.

Medical device software engineers and regulatory affairs staff who maintain the SOUP register for an IEC 62304 technical file: firmware and application teams shipping under EU MDR or FDA premarket submissions, and the contract developers who hand a register over to a manufacturer at the end of a project.

A markdown linter checks table syntax, not records; it cannot tell a pinned version from a caret range. An AI assistant will answer confidently and sometimes cite the wrong clause number. This extension applies one fixed rule set, prints the clause next to every finding, and gives the same answer twice.

Linting one SOUP list is free and complete: every gap in that file, every run, no item cap and no trial window. The same engine runs free in the browser. The licence adds workspace-wide scanning across several device repositories and the dated Markdown and CSV evidence record you file with the technical documentation.

A regulatory consultant reviewing SOUP documentation bills in the $150 to $250 per hour range, and a thirty-item register is a morning of that work, repeated at every version bump. The licence is $29 once, with a seven-day full refund, and it re-checks the register in seconds.