Multi-Agent FDA 513(g) Regulatory Pipeline Solver

Underwrite deploying multi-agent AI systems analyzing medical device mechanism of action to draft formal FDA 513(g) requests and establish predicate product classification routes.

Clients & Classification SOWs

Active MedTech 513(g) Retainer Clients

Monthly Continuous Classification Monitoring Retainer ($ / client / mo)

Custom Enterprise 513(g) Pipeline Builds / 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

+$798,400 / yr (92.8% Margin)

Predictable Monthly Regulatory Retainer MRR

$50,000 / mo