Cruxi

AI-powered platform for medical device regulatory submissions with automated compliance checks and human review.

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About Cruxi

Cruxi is an AI-powered regulatory submission platform designed for medical device teams. It automates FDA 510(k), De Novo, PMA, IDE, and global filings by leveraging AI-driven device classification, predicate finding, and eSTAR drafting. The platform performs automated RTA (Refusal to Accept) compliance checks, evidence planning, and package export while incorporating human-in-the-loop review to ensure accuracy. Cruxi’s models are trained on FDA guidance and regulatory databases, providing traceable citations with zero-hallucination claims. It offers continuous regulatory updates and enterprise-grade security to help teams accelerate submissions, reduce refusal-to-accept risks, and produce reviewer-ready dossiers. The platform is tailored for medical device manufacturers, regulatory affairs professionals, and compliance teams seeking efficient and compliant submission processes.

Key features

AI-driven device classification and predicate finding
Automated eSTAR drafting for FDA submissions
Real-time RTA compliance checks
Evidence planning and package export
Human-in-the-loop review for accuracy
Traceable citations with zero-hallucination claims
Continuous regulatory updates
Enterprise-grade security
Support for FDA 510(k), De Novo, PMA, IDE, and global filings
Reviewer-ready dossier generation

Use cases

Preparing FDA 510(k) submissions for medical devices
Streamlining De Novo and PMA filings with compliance checks
Managing global regulatory submissions with automated workflows

Pros

AI-powered device classification and predicate finding for accurate regulatory pathway identification
Automated Refusal to Accept (RTA) compliance checks to reduce submission risks
Supports multiple regulatory pathways including FDA 510(k), De Novo, PMA, IDE, and global filings
Provides traceable citations with zero-hallucination claims through FDA guidance-trained models
Offers expert guidance and human-in-the-loop review for submission accuracy

Cons

May require initial technical adjustments during onboarding for some users
Dependent on regulatory updates, which may necessitate periodic retraining of AI models

Frequently asked questions about Cruxi

What regulatory pathways does Cruxi support?

Cruxi supports FDA 510(k), De Novo, PMA, IDE, Q-Submission, 513(g), PMA Supplements, HDE, Breakthrough Device Designation, Safer Technologies Program, CLIA Waiver, EU MDR, UKCA, Health Canada MDL, and Australia TGA pathways.

Who is Cruxi designed for?

The platform is tailored for medical device manufacturers, regulatory affairs professionals, and compliance teams seeking efficient and compliant submission processes.

Does Cruxi offer any expert support?

Yes, Cruxi provides expert guidance at every step of the submission journey and connects users with verified regulatory consultants and service providers.

How does Cruxi ensure submission accuracy?

Every submission undergoes automated compliance checks, multi-layer validation, and human-in-the-loop review to ensure alignment with FDA expectations and regulatory precedent.

Can Cruxi help with global regulatory submissions?

Yes, Cruxi supports global regulatory services including EU MDR, UKCA, Health Canada MDL, and Australia TGA submissions.

What is Cruxi's pricing model?

Cruxi offers a platform with AI-powered workflows and expert guidance, with access to regulatory directories and service providers; specific pricing details are available upon request.