Where Regulatory Intelligence Meets Human Expertise
QMB is a regulatory consultancy built to radically improve how MedTech companies prepare, manage, and succeed in new product development and FDA submissions.
QMB exists because compliance was never meant to slow you down.
QMB is for MedTech founders stuck in regulatory limbo, waiting on slow, outdated systems.
For every RA/QA team buried in paperwork instead of launching products.
For every innovator who knows that speed, clarity, and FDA success shouldn't be opposites.
Because regulatory success isn't about box-checking—it's about strategic execution, risk visibility, and confident momentum from day one.
We built QMB to help MedTech companies break free from bottlenecks and move at the speed of innovation—powered by AI, guided by experts, and built for what's next.
Our Mission
To elevate human well-being by harnessing the power of AI to empower MedTech innovators to accelerate regulatory success.
At the heart of our platform is QualiVerse®—the first AI-native engine purpose-built for regulatory strategy and submission preparation. It rapidly analyzes your product, identifies the correct regulatory path, flags risks, and generates FDA-ready documentation in minutes. But speed alone isn’t enough.
That’s why every submission powered by QualiVerse is backed by our expert-in-the-loop model, ensuring human oversight, accuracy, and confidence from start to finish.
We don’t just help teams get to market—we help them get there faster, smarter, and with a higher likelihood of approval.
We don’t see compliance as a hurdle—it’s a strategic advantage. QMB combines speed, intelligence, and expert oversight to help you move to market faster and with greater assurance.
Meet the founders
QMB Advisory Board
Our advisors guide QMB's innovation strategy within
evolving global regulations:
Ready to Transform Your Compliance?
Join leading MedTech companies who trust QMB to accelerate their regulatory journey.
Book a DemoBuilt by Regulatory Pros. Trusted by MedTech Leaders.
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.
Raj
CEO of GuideAlHealth
Experience the Future of Regulatory Compliance.
QMB helps MedTech innovators move faster, stay compliant, and build safer from day one.