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 and a minimum of $50,000 in consultant fees.
But the bottleneck starts even earlier: planning formative studies, searching FDA MAUDE for relevant adverse events, generating recruitment screeners, and designing study protocols. Each step is formulaic, repeatable and brutal to produce by hand.
Submitta automates the entire workflow from study planning to final report so your device reaches patients faster.
Traction
Running design partnerships with medical device companies and clinical research organizations. Early customers shape the roadmap while we iterate fast on the beta.
"Every day a device is not on the market costs companies $20K–$60K in lost revenue."
Leadership Team
Human factors engineers, and AI leader.
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.