QMB is a regulatory intelligence system that transforms how MedTech companies prepare, manage, and succeed in new product development and FDA submissions. We are a vertical SaaS platform augmented with expert embedded solutions.
QMB is for MedTech founders stuck in regulatory limbo, waiting on slow, outdated systems.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.
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.
Chairman & CEO of Quality Means Business (QualiVerse®), is a MedTech regulatory authority and product architect with 15+ years of experience, blending SaaS mastery from ETQ Reliance & ComplianceQuest with dual Master’s degrees in Engineering and Business from Boston University.
Business school professor, corporate lawyer, and technology executive with extensive experience in high-growth companies. Former General Counsel and senior executive in enterprise software and security sectors. Professor at Boston College Carroll School of Management focusing on high-performing teams and business solutions consulting. Graduate of Colby College and Boston College Law School.
B2B marketing strategist and leader with 11+ years in strategic marketing and business development in the tech services and SaaS industries. Experienced leader in GTM strategy, ABM, demand generation, and full-funnel digital marketing with an emphasis on startup GTM execution, investor and partner engagement, customer acquisition and retention, and market positioning.
Quality and Regulatory leader with 15+ years in life sciences, medical devices, biotech, and pharma. Expertise in FDA, EU MDR, and ISO standards across Class I–III devices and combination products. Experienced in risk management, validation, and building scalable Quality Management Systems that drive compliance and efficiency
Join leading MedTech companies who trust QMB to accelerate their regulatory journey.
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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.
