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Adam Camisleft a comment
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....
Cruxi510k submission services
Professional 510(k) submission services powered by a chain of trained AI agents. A complete FDA 510(k) platform with automated classification, predicate analysis, regulatory assessment, and eSTAR-ready drafting and editing. Designed to help medtech teams move from idea to FDA clearance faster and enhance quality.
Cruxi510k submission services