About Cruxi
Accelerating regulatory processes for the good of patients
Our Mission
Cruxi's mission is to accelerate regulatory processes for the good of patients. We believe that every day a life-saving medical device is delayed in reaching patients is a day too many. By building AI-powered tools that streamline FDA submissions, reduce time-to-market, and eliminate regulatory bottlenecks, we're helping bring innovative medical devices to patients faster—ultimately saving lives and improving healthcare outcomes.
Why We Exist
The regulatory submission process shouldn't be a barrier to innovation
The Problem
Medical device companies spend 6-12 months preparing FDA submissions, navigating complex regulatory requirements, and waiting for approvals. This lengthy process delays life-saving innovations from reaching patients who need them.
- scheduleMonths of manual document preparation
- errorHigh risk of RTA (Refuse to Accept) rejections
- trending_upRising regulatory consulting costs
- peopleLimited access to regulatory expertise
Our Solution
We've built an AI-powered platform that automates the entire regulatory submission workflow—from device classification to final packaging. Our tools reduce preparation time by 50-70% while maintaining the highest quality standards.
- auto_awesomeAI-powered automation at every step
- verifiedRTA prevention built into the workflow
- speed3-4 months instead of 6-12 months
- savingsReduced consulting costs and faster time-to-market
Our Values
The principles that guide everything we do
Patient-First
Every decision we make is guided by one question: How does this help patients get access to life-saving medical devices faster?
Quality & Compliance
We never compromise on quality. Every submission we help create meets the highest FDA standards and regulatory requirements.
Innovation
We continuously push the boundaries of what's possible with AI and regulatory technology to solve complex challenges.
Transparency
Every claim we make is traceable to source documents. Zero hallucinations. Complete transparency in our AI-powered processes.
Accessibility
We believe regulatory expertise shouldn't be limited to large corporations. Our tools make professional-grade submissions accessible to startups and innovators.
Continuous Improvement
We learn from every submission, every FDA interaction, and every user feedback to continuously improve our platform and processes.
What We Do
Comprehensive regulatory solutions for medical device companies
Complete 510(k) Submission Platform
From device intake to FDA clearance, our platform guides you through every step of the 510(k) submission process. AI-powered classification, predicate analysis, regulatory assessment, eSTAR drafting, and submission packaging—all in one integrated workflow.
- check_circleEnd-to-end submission workflow
- smart_toyAI-powered content generation
- shieldAutomated RTA prevention
- folder_managedComplete document management
Standalone Microservices
Use our individual tools as needed—device classification, predicate finding, regulatory assessment, or RTA checking. Each microservice works independently or integrates seamlessly with the complete workflow.
- appsModular, flexible architecture
- integration_instructionsEasy integration with existing workflows
- boltFast, focused solutions
- paymentsPay only for what you use
Our Impact
Helping bring medical devices to patients faster
Time Reduction
Faster submission preparation compared to traditional methods
RTA Prevention
Success rate in preventing Refuse to Accept issues
Successful Submissions
Medical device companies trust Cruxi for their submissions
Join Us in Our Mission
Whether you're a medical device startup or an established manufacturer, we're here to help you navigate the regulatory landscape and bring your innovations to patients faster.
Start Your Submission