AI-powered compliance intelligence that cuts your 510(k) submission time by 50% and predicts rejection risks with 92% accuracy
Every rejection means lost revenue, delayed market entry, and frustrated teams
Manually searching through thousands of 510(k) submissions takes weeks and often misses the best matches
Missing sections, incorrect formatting, and inadequate substantial equivalence arguments sink submissions
FDA guidance updates constantly. One missed change can derail months of preparation
Every tool you need to ensure FDA approval on the first submission
AI analyzes your device and finds the most successful predicates in seconds, not weeks
Upload your draft 510(k) and get instant feedback on completeness, compliance, and rejection risks
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Never miss a guidance change. We monitor FDA daily and alert you to relevant updates
Auto-generate FDA-ready documents with proper formatting and required sections
Our AI predicts your approval probability and highlights exactly what needs fixing
Our AI guides you through the entire FDA submission process
Import device specifications, test results, and draft documentation
Our system analyzes compliance, finds predicates, and identifies gaps
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Save hundreds of thousands in rejection costs for less than the price of one consultant hour
Join forward-thinking medical device companies using AI to ensure compliance
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