Your Fast Lane to the FDA
Submitta was founded by a human factors engineer, and an AI expert who saw regulatory documentation bottlenecks delay life-saving devices from reaching patients.
The Problem We Solve
Getting a medical device cleared by the FDA requires a Human Factors report, a dense technical document proving the device is safe for real-world use. A first draft takes 2-3 months to produce by hand.
The bottleneck starts even earlier. Planning formative studies. Searching FDA MAUDE for relevant adverse events. Generating recruitment screeners. Designing study protocols. Each step is formulaic, repeatable, and time-consuming to build from scratch every time.
Submitta automates the entire workflow, from study planning to report drafts, so engineers spend less time on paperwork and more time on the testing, judgment, and next-generation devices that actually need their expertise. Devices reach patients faster, and the people building them get their time back.
Tour the Tedious Human Factors Study Workflow Now
One month later....
Leadership Team
A human factors engineer and an AI leader, building together.
Thibaud Cholat
Co-Founder
AI practitioner who specializes in transforming engineering teams through modern practices and applying AI in ways that drive measurable impact. He brings a grounded perspective on how organizations can successfully adopt and scale AI
Anushka Bhide
Co-Founder
Human factors engineer with experience applying regulatory & human factors principles to surgical robotics, digital PTSD therapies, and rehabilitation equipment
The Documentation Has Not Changed.
The Time Required to Produce It Is About To.
Get Submitta into your environment, deliver real impact, and accelerate your path to market.