Your Fast Lane to the FDA
From formative study planning to final HF reports. Submitta automates usability regulatory documentation so your device reaches patients faster.
Every day a device is not on the market it costs companies $20K–$60K in lost revenue.
From Study Planning to Final Report
Submitta assists with the full human factors workflow : MAUDE searches, recruitment screener generation, formative study planning, identifying user groups and FDA-compliant report automation.
HF Study Advisor
A leading cause for FDA rejection is choosing the wrong user groups for usability studies. The goal of this tool is to reduce risk of redoing expensive studies. We deliver a recruitment screener, scrape FDA adverse events with similar devices, and suggest study design.
HF Usability Report
Human factors engineers spend 2-3 months out of a year drafting study reports. Within minutes, our Reporting tool generates a draft report for review. Also rewords formative questions, saving time and improving accuracy.
Design Change Analyzer
Sometimes, small changes to in-market device designs don’t require re-validation or re-submission. Our design change analyzer tool helps teams assess their design change in detail and suggests either re-submission or drafting an equivalency memo.
FDA Guidance Built In
Deep, continuously updated integration with FDA Human Factors guidance. Every output applies current regulatory standards automatically.
Your Data Is Yours
Customer data is fully isolated. Submissions are never used to train models across accounts. Enterprise-grade encryption at rest and in transit.
Why Device Teams Choose Submitta
See the real impact in minutes, not weeks
Analysis time compressed 100x
10+ hours
Consulting time eliminated
Significantly reduced cross-functional meetings
✓ Bonus
Reusable equivalency memo template
"We had a design change, and our team questioned if a new Human Factors study was required. This would normally take our team several weeks to outline, cross-check documentation, and assess."
"With Submitta's Design Change Analyzer, we had complete risk and usability impact analysis plus Q-sub recommendations in minutes. The depth genuinely surprised us—it flagged considerations we hadn't discussed."
"Submitta drafted an equivalency memo with a reusable template. It saved us weeks of back-and-forth. This is exactly what medical device teams need to go fast without cutting corners."
Global Product Director, Thermasolutions
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.