Draft your 510(k) submission
with
User Augmented Multi-Model Intelligence
Join our exclusive pilot program and be one of the first to experience how our unique Ai software can save you time by 10x, reduce costs by 5x, and streamline your 510(k) submission process.
SE.ai is an Ai-powered tool designed to automate the most time-consuming parts of FDA 510(k) submissions, starting with the Substantial Equivalence section.
Our MVP will help you generate submission documents faster, saving you months of work.
Our Promise to You
Save time
The average 510(k) documentation prep takes 580+ hours.
Stop wasting your time memorizing standards and formatting, and spend it perfecting the details so your team can focus on hitting your deadlines.
Save money
The average cost of a regulatory consultant is over $200/hour.
If you're tired of spending precious investment capital for half-baked answers, try drafting real text with our prompt engineering and your existing documentation.
Increase confidence
Over one-third of 510(k) submissions fail the minimum acceptability check.
Generate the Substantial Equivalence section of your application now, with built-in formatting and confidence scoring from our exclusive database of successful past submissions.
What participants will get
Exclusive Early Access
Be among the first to use SE.ai’s Ai-powered tool to streamline your FDA 510(k) submission process, gaining a competitive advantage and a head start on regulatory approval.
Personalized Support
Receive dedicated assistance from our team of Ai and regulatory experts to help you navigate the tool, answer any questions, and optimize your submission strategy.
Shape the Future of MedTech Innovation
Provide critical feedback that will directly influence the development and features of SE.ai, helping to refine a solution that could transform the industry.
How it works
Sign up and follow our prompts for categorizing your device.
Our Ai generates a first draft of your Substantial Equivalence section.
Receive feedback from our regulatory experts and fine-tune your submission.
We will only accept 10 participants on a first-come-first-service basis.
Don't miss your chance to be part of the future of 510(k) submissions.
Apply for the pilot program today!
FAQ
What does the pilot program involve?
As a participant in our initial pilot program, you will receive exclusive access to our first-generation software built to provide the full text of your Substantial Equivalence 510(k) section for your device.
How will I benefit from participating?
We will help you categorize your device properly based on its intended use, and your output will be formatted and drafted utilizing current FDA 510(k) submission standards and referencing over 50k successful past submissions.
What kind of support will I receive?
Our pilot participants will receive a white-glove treatment by our team. We'll help you with everything from navigating prompt inputs to utilizing additional resources.
Meet the Team
Leon Zheng,
Founder and Co-CEO
Medical Device Innovator & Serial Entrepreneur
Having founded and exited on several medical device startups in the United States and abroad, Leon has successfully navigated the FDA approval process multiple times. He has personally designed, received approval for, and manufactured devices from infrared temperature sensors to radiosurgery treatment devices which have saved the lives of over 30k patients worldwide. Leon holds 15 international patents for his technologies and has been in the medical device field for over 25 years. He has a strong passion for Ai and its potential to boost innovation.
Wren Gregory, PhD,
Founder and Co-CEO
Physicist & Clinical Regulatory Expert
During her doctorate, Dr. Gregory developed, synthesized and manufactured novel diagnostic nanoparticles for cancer drug delivery. With over a decade of regulatory experience, she has extensive experience in medical device and SaMD clearance in the US and EU. Wren is a compliance specialist in diagnostic testing and medical devices who has spearheaded groundbreaking SaaS platforms to tackle the opioid crisis via risk stratification and precision medicine regimen calculators deployed nationwide. She has a strong passion for Ai and its potential to empower entrepreneurs.
Andrew Disharoon,
Founder and CTO
Chief Data & Machine Learning Scientist
Formally trained in Genetics and Biochemistry, Andrew leads a Bioinformatics Department for a precision medicine CRO. He has developed Machine Learning models for drug interaction prediction, boasting better performance than the leading published models in the space and resulting in documented improved patient outcomes. Andrew has extensive experience in artificial intelligence applications, IT security, and compliance standards for software and medical devices in both the United States and the European Union.