Become an SE.ai Partner
Define your strategy, find your predicate device, and draft your first document in ONE hour!
Fast-track your innovation
Confidently navigate your FDA 510(k) in less time, guaranteed.
Our promise
Build your FDA application from scratch.
The FDA’s 510(k) process takes an average of three years of runway to execute to approval. Don’t let your medical device get lost in the process.
5X time savings
Traditional documentation preparation for submissions takes 580+ hours. Our customized AI tools are designed to tackle critical steps in 80% less time.
10X cost savings
The average cost of a regulatory consultant is over $200 per hour. Let our AI do the initial work so you can bring on experts where it matters most.
Increased confidence
Over one-third of submissions fail the RTA minimum acceptability check. Benchmark your application next to tens of thousands of successful documents.
Skip months of uncertainty!
Get a clear 510(k) pathway, predicate matches, and SE gap analysis in minutes with SE.ai’s FastMap tool. Sign up now and instantly receive $195 worth in platform credits(Koins).
we’ve been in your shoes
Our Team
As seasoned medtech professionals with expertise in medical device development, we are united by a shared mission to revolutionize medical innovation by bringing more lifesaving technologies to patients. Drawing from decades of combined experience in designing and advancing cutting-edge devices, we’ve created an AI-enabled software platform just for you.
Data
Security
Data is encrypted in transit and at rest. We never use your proprietary device information or submission drafts to train our public models.
Output
Transparency
Grounded in our proprietary database & models, the system creates a verifiable audit trail, turning AI output into a defensible, reviewer-ready rationale.
Workflow
Adaptivity
Adapting to your preferred starting point and supplementing your expertise without demanding a complete overhaul of your trusted regulatory SOPs.
SE.ai News
Stay informed on current news and events in medtech with our our team. We deep dive into regulatory topics, can’t miss networking events, marketing advice, and exclusive interviews with successful medtech pioneers.
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