Cruxi: 510k submission services

This is a very niche product. It’s built for medtech founders, RA/QA teams, and regulatory consultants who live in the world of 510(k)s, product codes, predicates, guidance docs, test plans, and eSTAR. If that sounds like another planet, that’s totally okay – Cruxi is probably not meant for you 🙂 We started building Cruxi after seeing how painful and expensive 510(k) work is for small teams. You’re trying to build a device, raise money, and learn FDA language at the same time – then you hit classification, predicates, testing requirements, and eSTAR formatting, and everything either slows down for months or gets outsourced for five figures. Cruxi tries to turn that chaos into something structured and actionable: classify your device and map it to the right regulation/product code surface relevant predicates, guidance, and safety data outline likely testing and documentation expectations draft eSTAR-ready sections you can review with your RA/QA team or consultant The first versions were basically “smart search” over FDA data. We quickly realized no one wanted yet another search box – they wanted a chain of agents that actually do the work: read the regulations, score fit, propose predicates, and turn that into a concrete plan and draft content. Cruxi is not a replacement for experienced regulatory professionals. It’s meant to make their work (and their clients’ lives) less painful and more predictable, especially for teams without big RA budgets. Because this is so specialized, we really appreciate kind, constructive feedback from people who work in: medtech / digital health regulatory affairs / quality consulting around FDA submissions If this isn’t your domain, feel free to just be curious or ask questions rather than judge it by consumer-product standards. And if you are in this space, we’d love to hear what would make Cruxi genuinely useful in your day-to-day work. 💙