Modern Regulatory Solutions, Built for MedTech
QMB is the world’s first Regulatory Intelligence System that blends AI automation with deep expertise to help MedTech teams reach FDA success faster, smarter, and with less risk.
What We Offer
Our platform is structured around three powerful categories
designed to meet you where you are—whether you need strategic guidance, expert-backed automation, or compliance confidence.
AI-powered FDA submissions, built for speed and certainty.
QualiVerse® is our proprietary engine that accelerates the most complex part of MedTech development—FDA submissions. We combine advanced AI document generation with regulatory risk modeling and expert oversight to reduce time, cost, and uncertainty.
FDA Regulatory Submission Readiness Review
510(k), De Novo & PMA Submission Pathway Determination.
Predicate Device Analysis
FDA Strategy and Content Development
Regulatory Risk Scoring (7-Point AI Model)
Expert-in-the-Loop Submission Review
AI-Powered Submission Document Generation
Define the right path. Deliver with confidence.
We partner with you to identify the optimal FDA path, prepare compliant submission packages, and ensure your team is aligned for success—from initial roadmap to final clearance.
Regulatory Strategy & Roadmapping
Regulatory Pathway Mapping & Submission Planning
Regulatory Gap Assessments
Submission Content Build & Review
Risk Identification and Mitigation
Regulatory Staff Augmentation
Build scalable systems. Prepare for inspection. Stay ready to grow.
We support MedTech innovators across their full quality and clinical lifecycle—from standing up a QMS to preparing for audits and running compliant trials.
QMS Design & Deployment
eQMS Migration and Optimization
FDA Audit Readiness and Remediation (CAPAs, 483s, WLs)
Clinical Trial Oversight and Operational Support
Clinical Verification & Validation Strategy
GxP Training and Documentation
Trusted by
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.
