Cruxi

Cruxi

510k submission services

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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.

Cruxi makers

Here are the founders, developers, designers and product people who worked on Cruxi

Adam Camis
Adam CamisAI copilot for FDA 510(k) submissions
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