Cruxi
A platform for regulatory submissions of medical devices with compliance checks and human review.
Pricing
Paid
Category
Finance
Open source
No
In the database since
Dec 2025
Overview
About Cruxi
Cruxi is an AI-powered regulatory submission platform for medical device teams that automates FDA 510(k), De Novo, PMA, IDE and global filings by using AI-driven device classification, predicate finding, eSTAR drafting, automated RTA/compliance checks, evidence planning and package export combined with human-in-the-loop review; its models are trained on FDA guidance and regulatory databases with traceable citations (zero-hallucination claims), continuous regulatory updates, and enterprise-grade security to help teams move faster, reduce refusal-to-accept risks, and produce reviewer-ready, submission-quality dossiers.
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