Cruxi

What is Cruxi?

Cruxi is an AI-powered regulatory submission platform that streamlines FDA 510(k), De Novo, PMA, IDE, and global regulatory submissions for medical device companies. Our platform automates device classification, predicate finding, regulatory assessment, eSTAR drafting, and submission packaging.

How does Cruxi help with FDA 510(k) submissions?

Cruxi provides a complete end-to-end workflow for FDA 510(k) submissions, including AI-powered device classification, intelligent predicate device identification, automated regulatory assessment, eSTAR section drafting, RTA prevention checks, and complete submission packaging. This reduces preparation time by 50-70% while maintaining the highest quality standards.

What regulatory services does Cruxi offer?

Cruxi offers 14 regulatory services covering FDA and global markets: FDA 510(k), De Novo Classification Request, PMA Supplements, IDE Submissions, Q-Submission (Pre-Sub), 513(g) Request, Humanitarian Device Exemption (HDE), Breakthrough Device Designation, Safer Technologies Program (STeP), CLIA Waiver (IVDs), EU MDR Technical Documentation, UKCA Dossiers, Health Canada MDL, and Australia TGA ARTG.

How does Cruxi prevent RTA (Refuse to Accept) issues?

Cruxi has automated RTA prevention built into the workflow. Our platform performs pre-submission readiness checks that validate completeness, format compliance, and required documentation. The system identifies potential RTA issues before submission, helping achieve a 90% success rate in preventing Refuse to Accept issues.

Is Cruxi suitable for startups and small medical device companies?

Yes, Cruxi is designed to make professional-grade regulatory submissions accessible to startups and innovators. Our platform provides the same high-quality regulatory expertise and tools that large corporations use, making it affordable and accessible for companies of all sizes.

What makes Cruxi different from traditional regulatory consultants?

Cruxi combines AI-powered automation with expert guidance, reducing submission preparation time by 50-70% compared to traditional methods. Our platform provides real-time compliance checks, automated content generation, and comprehensive RTA prevention, while maintaining the highest FDA quality standards. Every claim is traceable to source documents with zero hallucinations.