ABOUT QMB

Compliance was never meant to slow you down

QMB builds QualiVerse®, the Regulatory Operating System delivering Regulated Lifecycle Intelligence for MedTech product development, so teams reach submission readiness faster, with regulatory experts reviewing every output.

See how QualiVerse® works

TRUSTED BY MEDTECH TEAMS

OUR STORY

Born from years inside the FDA submission room

QMB was founded in 2022 by a multidisciplinary team, spanning engineering, AI and software, product architecture, regulatory strategy, quality, clinical care, pharmacy, and business, who had each spent years navigating the slow, expensive, and error-prone path to FDA clearance from a different seat at the table. They kept seeing the same pattern: strong MedTech innovation held back by paperwork, not by science.

So they built a single intelligent system for the regulatory pathway. QualiVerse® determines the correct regulatory pathway, generates the Evidence Generated Artifacts a submission requires, and validates that structure against FDA expectations, with compatibility for the eSTAR portal. Every output is reviewed by a regulatory brain trust of seasoned professionals before it reaches a reviewer, so speed never comes at the cost of getting it right.

QualiVerse® is the product this team built, not another quality management system and not a template. It is the Regulatory Operating System for MedTech product development, with human expertise built into every step.

See it against your own program

WHAT WE STAND FOR

To elevate human well-being by harnessing the power of AI to transform and accelerate MedTech’s innovation cycles.

Speed without cutting corners

Fast and rigorous, never one at the expense of the other. We do not cut corners.

Human Judgment by Design

QualiVerse was built for regulatory professionals, with workflows that allow experts to review, challenge, refine, and redirect the analysis at every stage. It strengthens regulatory decision-making without replacing the expertise behind it. For teams without dedicated regulatory professionals, QMB expert support hours can be added to provide experienced regulatory guidance when needed.

Evidence over guesswork

Outputs are grounded in real regulatory evidence, not generative guesswork.

Modernization, not demolition

QualiVerse® sits on top of the systems you already run and extends your team. It does not replace it.

OUR TEAM

Built by a multidisciplinary team

Michel E. Moravia

Chairman of the Board of Directors and Chief Executive Officer

MedTech and life-sciences executive with 15+ years across quality, regulatory, engineering and digital transformation, including leadership experience across global healthcare and technology organizations. Dual master's degrees in engineering and business from Boston University.

Thaina C. Roman

COO and Co-Founder

Over 10 years in the medical field and primary care governance, with a master's degree in nursing. Champions operational quality and sustainable medical innovation.

Julian Weinstock

CTO

Architect of QualiVerse® with over 30 years of experience in AI, cloud, and SaaS, with degrees in computer science and electrical engineering.

Christopher J. Wallace

CISO and Co-Founder

Pharmacist and programmer with over 15 years of experience, ensuring quality-driven, user-centric technology and robust security across QMB.

Scott McDermott

Chief of Staff

Business school professor, corporate lawyer, and technology executive with extensive experience in high-growth companies, focused on building high-performing teams.

Leonard Glatkowski, PhD

EVP Regulatory and Customer Success, Co-Founder

Over 20 years of global regulatory strategy experience, with expertise in MDSAP, MDR, warning letters, and ISO certifications.

GOVERNANCE

Board of Directors

Orlando Watkins

Board of Directors

Orlando Watkins is Vice President and Chief Program Officer at the Boston Foundation, with a 30-year career spanning philanthropy, education, and government, including a Governor appointment as Executive Director of the Louisiana Serve Commission. He advises companies with double-impact missions and is a founding Board member of QMB.

Robert Bennett

Board of Directors

Bob Bennett brings three decades of experience building and scaling technology companies to QMB's board, most recently as CEO of EngageSmart (formerly Invoice Cloud) through its 2021 IPO and 2024 acquisition by Vista Equity Partners. He also serves on the boards of InvoiceCloud, SimplePractice, Forrester, and ShipMonk.