Regulatory Intelligence, Reimagined.
QualiVerse® is the first AI-native Regulatory Intelligence Engine built for FDA success—designed to automate submissions, flag risks, and deliver expert-validated compliance at scale.
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What Is QualiVerse®?
Built by regulatory experts, QualiVerse® merges generative AI with deep domain knowledge to deliver faster, more confident FDA submissions.
Instantly generates FDA-ready documentation
Identifies regulatory risks using a proprietary 7-point AI model
Centralizes workflow in a secure cloud workspace
Integrates Expert-in-the-Loop for validation
Determines classification, predicate devices, and strategy
Why It Matters
Smarter. Faster. FDA Ready.
Cut years off your new product development timeline. QualiVerse compresses your time-to-market
95%+ Submission Success Improve approval rates with real-time risk insights and expert review.
80% Faster Submission Prep.
>$1.65M in Cost Savings Avoid delays, rework, and endless consultant bills.
How It Works
From Product Concept to FDA Submission—All in One Platform.
AI determines classification, product code, and regulatory pathway
Risk flagged via 7-point model
Required documents drafted instantly
Experts review and refine
Submission-ready package delivered
Expert in the Loop
QualiVerse® doesn’t replace your regulatory team—it extends it. Every recommendation and output is reviewed by seasoned regulatory professionals to ensure clarity, accuracy, and submission-readiness.
Human Oversight: All outputs from QualiVerse® are carefully reviewed by experienced regulatory professionals.
Enhanced Accuracy: Expert review ensures recommendations are clear, precise, and compliant.
Team Extension: Rather than replacing your team, QualiVerse® strengthens it with expert support.
Who It’s For
Built for MedTech Innovators
MedTech Startups & Scaleups.
VC/PE-Backed Portfolio Companies.
RA/QA teams stretched thin.
As a Physician-led Al-enabled SaMD, we relied on QMB for all our regulatory compliance needs. What differentiate them above the rest is QualiVerse. QualiVerse was able to expedite selecting our product code, predicate device, and design planning documents in a record time for pre-submission with the FDA. This also augmented our investment efforts.
