Regulatory Certainty
in Seconds, Not Months
Scroll to explore
Intelligence that
works alongside your team.
We don't just fill forms. We generate strategic regulatory assets that would normally cost thousands of dollars.
Predicate Intelligence
Our AI reasons through FDA databases to find your path of least resistance, citing specific guidance documents.
Smart Scheduling
Dynamically sequences your submission timeline across 4 phases, preventing costly bottlenecks before they happen.
Cost Estimation
Granular, line-item breakdown of regulatory costs backed by real-world data and risk-based rationale.
Gap Analysis
Identifies specific testing gaps between your device and the predicate to ensure submission success.
Find your path of
least resistance.
The "Predicate Device Intelligence" module is our core differentiator. This technology doesn't just search—it reasons through FDA databases to identify cleared devices matching your technology while highlighting the exact gaps you need to bridge.
