Multi-Agent FDA 510(k) Regulatory Pipeline Solver

Underwrite deploying multi-agent LLM systems cross-auditing technical device specifications against thousands of FDA predicate device databases to streamline clearance submissions.

Clients & Regulatory SOWs

Active MedTech Regulatory AI Retainer Clients

Monthly Continuous Regulatory Compliance Retainer ($ / client / mo)

Custom Enterprise 510(k) Dossier Bots / Year

Average Pipeline Build SOW Fee ($ - e.g. $65,000)

Annual Consulting Financials

Annual Gross MedTech AI Regulatory Billings

$860,000 / yr

Net AI Specialist Pre-Tax Take-Home Income

+$804,400 / yr (93.5% Margin)

Predictable Monthly Regulatory Retainer MRR

$50,000 / mo