Cruxi

Cruxi is a comprehensive, AI-powered platform built to simplify and accelerate the complex process of medical device regulatory submissions. Designed for regulatory professionals and medical device companies, Cruxi automates the entire submission workflow, from initial device classification to the final submission package. The platform supports a wide range of services, including FDA 510(k), De Novo, PMA, and IDE submissions, as well as global market applications for the EU (MDR), UK (UKCA), Canada, and Australia. By leveraging AI trained on current FDA guidance and successful submissions, Cruxi aims to reduce preparation time by 50-70% and prevent costly Refuse to Accept (RTA) rejections.

How to use Cruxi

Users begin by utilizing the AI-powered classification tool to instantly identify the correct product codes and regulatory pathways for their medical device. The platform then assists in finding and analyzing predicate devices for substantial equivalence arguments. Users can draft their submission within the intelligent eSTAR editor, which provides AI-generated content suggestions and ensures consistency. Throughout the process, all supporting documents and evidence are managed centrally. Before finalizing, the system runs automated RTA checks to validate completeness and compliance. Finally, a perfectly formatted, submission-ready package can be exported for submission to regulatory bodies.

Core Features of Cruxi

• AI-Powered Device Classification: Automatically identifies product codes, regulation numbers, and classification pathways.
• Intelligent Predicate Finding: AI-driven identification and substantial equivalence analysis against a database of cleared devices.
• Automated RTA Checks: Pre-submission readiness checks to prevent Refuse to Accept (RTA) letters from the FDA.
• Intelligent eSTAR Editor: A professional editor for FDA eSTAR submissions with AI-assisted drafting, review, and export capabilities.
• Evidence Planning & Management: Intelligently maps evidence requirements and helps organize all supporting documents with compliance tracking.
• Compliance Advisor: Provides AI-powered reviews and recommendations based on current regulatory requirements and best practices.
• Multi-Jurisdictional Support: Covers 14 different regulatory services for the FDA and global markets including the EU, UK, Canada, and Australia.
• Zero Hallucinations Guarantee: Ensures every claim and data point is traceable to its source, synthesizing information only from verified regulatory databases and user-provided documents.

Use Cases for Cruxi

Cruxi is ideal for regulatory affairs professionals, quality assurance specialists, and product managers at medical device companies of all sizes, from startups to established manufacturers. It is particularly useful for teams preparing FDA 510(k), De Novo, PMA, or IDE submissions. The platform also serves companies seeking to expand into global markets by streamlining the creation of technical documentation for EU MDR, UKCA, Health Canada, and Australia TGA requirements.

Advantages of Cruxi

The primary advantage of Cruxi is its ability to dramatically increase efficiency and accuracy in regulatory submissions. It reduces manual preparation time by 50-70%, allowing for a faster time-to-market. Its automated RTA prevention has a high success rate, saving months of delays. The AI is aligned with FDA guidance and reviewer psychology, structuring content for easier comprehension. The platform ensures enterprise-grade security with SOC 2 Type II, HIPAA, and GDPR compliance, protecting sensitive data.