Comment by jgable
18 hours ago
I’m developing BaseRef (https://getbaseref.com), a requirements/risk/test management and documentation SaaS tool focused on medical device startups. There are competitors in the space but most are enterprise tools for enterprise customers. My primary differentiators are reasonable up-front prices, and easy inclusion of traced items in a wiki/notion-like collaborative document editor. It’s not a sexy or original idea, but I think there is a gap in the market for a solid business. I’ve been an embedded software consultant for medical device startups for years, but this is my first SaaS business.
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.