AI-powered FDA pathway assessment, compliance checklists, submission templates, and real-time regulatory alerts — built for health tech founders who can't afford to get it wrong.
Get My Free Checklist →"Provide general knowledge about what they see, in a simple way and result oriented — not teaching clinical science or underlying mechanisms"
"You don't have any first hand clinical knowledge, and you're competing against people who studied data analytics"
"The regulatory landscape is changing faster than consultants can keep up — founders need real-time guidance, not quarterly check-ins."
Answer structured questions about your product. Our AI determines your FDA classification, pathway, and requirements.
Dynamic checklists generated for your specific product type, pathway, and development stage. Never miss a requirement.
Pre-built submission templates for 510(k), De Novo, PMA, and software-as-medical-device (SaMD) pathways.
Real-time notifications when FDA guidance changes affect your product category. Stay ahead, not behind.
Physician-validated clinical input ensures your product's medical claims and clinical classification are accurate.
Track your regulatory milestones, document completion, and readiness score in one clear dashboard.
Tell us about your health tech product — what it does, what claims you make, who uses it.
Our engine determines your regulatory pathway, classification, and specific requirements.
Follow dynamic checklists and use templates to build your regulatory submission package.
Get real-time alerts when regulations change and track your progress to submission readiness.
Clinical classifications reviewed by a practicing physician who understands medical device categorization from the clinical side.
Your product details and regulatory strategy are encrypted and never shared. NDA-level protection by default.
FDA guidance changes constantly. Our AI monitors and alerts you instantly — no more quarterly consultant check-ins.
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