Comment by HeyLaughingBoy

That's interesting. Traceability from Requirements to Architecture & Design (in both directions) is an issue that I've thought of building a tool for after coming across some projects that were doing a bad job of managing it. Risk & HA seem like they'd want to be in a separate tool, though.

Suggestion for your landing page: state what FDA submission docs the tool will generate and maybe mention 62304 compliance.