MaudeSignal

MaudeSignal is a B2B regulatory support tool that helps medical device teams watch devices after they are sold. When a complaint lands, it searches FDA's public MAUDE database live via openFDA, checks the device type, flags sudden report increases, and prepares a PMS evidence pack with an FDA escalation path and a recall-need check. Every sentence is checked by a claim gate against the records, every number links to its openFDA query, and every step lands in an audit trail. A named person reviews and decides any CAPA — the tool never decides, never gives medical advice, and nothing is filed with FDA. It is built for post-market surveillance teams, not patients. Live at https://maudesignal-app.vercel.app/ , public repo in the GitHub field below, with a user manual, MCP connector, morning brief, and EU workflow using FDA data only.