Quality Means Business

Founded in 2022, based in the US, by Michel Moravia, QMB, Inc. specializes in regulatory compliance solutions for MedTech companies, utilizing AI-driven technology to enhance product development and FDA submission processes through its QualiVerse platform. QMB, Inc. was founded in 2022 and is headquartered in the United States.

The company focuses on providing innovative solutions for regulatory compliance in the MedTech sector. In November 2025, the company secured USD 2 million in Seed funding, co-led by Boston Foundation and CEI Ventures Management, to support its growth. QMB, Inc. offers a comprehensive suite of products and services designed to streamline regulatory compliance for MedTech companies, with a primary focus on the QualiVerse platform.

This innovative solution leverages artificial intelligence and regulatory expertise to automate the New Product Development (NPD) process and facilitate FDA submissions. By providing features such as automated documentation generation, predicate device classification, and risk flagging, QualiVerse transforms regulatory bottlenecks into strategic advantages for its users. The platform serves a diverse clientele, including life sciences companies and MedTech innovators, across various geographical markets including the United States, Europe, and regions adhering to global regulatory standards like ISO 13485 and EU MDR. By enabling faster and more efficient regulatory processes, QMB supports its clients in effectively navigating compliance challenges and accelerating their product launches.

QMB, Inc. generates revenue primarily through a subscription-based model for its flagship product, the QualiVerse® platform. Clients engage in contractual agreements that may involve annual or monthly subscriptions, which grant access to various functionalities essential for regulatory compliance and product development. These transactions typically cater to B2B interactions, where life sciences companies leverage the platform to optimize their regulatory pathways.

The pricing structure is designed to accommodate varying client needs and scales based on the specific services utilized, including documentation automation and expert oversight. The organization's revenue streams are bolstered by offering tailored support and advisory services for clinical trial management and quality management system transitions, further enhancing the value provided to clients in the MedTech sector. In November 2025, QMB, Inc. raised USD 2 million in Seed funding to enhance its engineering team and improve its platform for medical device manufacturers.

The funding will enable the company to develop upcoming products aimed at increasing the efficacy of their existing solutions. Furthermore, QMB is strategically planning to expand its presence in international markets, targeting specific regions by the end of 2026, solidifying its commitment to streamlining regulatory processes globally.