Introducing Quality Means Business: OS for QA/RA teams in life sciences

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From Regulatory Fatigue to Enthusiastic Engagement:

In my tenure as CEO of a diagnostic startup, I vividly recall a regulatory meeting where I succumbed to jetlag-induced sleep as our FDA consultant delved into human factors analysis and risk mitigation strategies. To be fair, I had just returned from the European Society of Cardiology Congress in Paris and was battling jetlag. Still, regulatory affairs felt overwhelmingly tedious.

Fast forward to my first meeting with Michel Moravia, CEO of QMB. Despite a sleepless night tending to my 5-month-old, I found myself invigorated by our discussion on the pivotal role of Regulatory Affairs and Quality Assurance (RA/QA) in product development. Michel's emails, always signed with "Yours in Quality," epitomize his dedication to transforming RA/QA through QMB's AI-powered system, turning regulatory challenges into streamlined pathways for innovation.

Why We’re Excited About Quality Means Business (QMB):

Revolutionizing Life Science Regulatory Approvals - QMB is addressing one of the most critical bottlenecks in healthcare product launches by leveraging AI to transform the Life Science regulatory process. With 64% of 510(k) applications being rejected, with over 30% failing at the initial screening stage due to avoidable administrative errors,** the stakes are immense as the average cost to bring a new medical device to market exceeding $24M and. QMB’s software platform (Qualiverse) turns regulatory affairs from a cost center into a strategic profit center by enabling faster approvals, fewer errors, and actionable insights for future submissions. As the first SaaS operating system for RA/QA teams, Qualiverse holds the potential to disrupt the traditionally manual and consultant-reliant workflow regulatory space with an integrated, lightweight solution, much like Stripe revolutionized payments with API and Workday streamlined HR operations.

Demonstrated Early Traction - QMB has validated both product-market fit and willingness to pay, with signed 7-figure potential ARR contracts with a leading regulatory consulting group (licensing and marketing agreement) and global top 5 medical device company ($20B+ 2024 revenue). This pipeline alone supports 2025 software revenue projection of $1.5-$2M ARR, demonstrating a clear path to scaling revenues. This does not take into account additional consulting services that add up to projected $4M in revenue in 2025.

Proven Founding Team - QMB is led by Michel Moravia, a seasoned executive with over 15 years of experience at global Life Sciences leaders like AbbVie, Fresenius, and Danaher. Michel’s deep understanding of regulatory affairs and quality systems uniquely positions him to tackle the challenges of building an RA/QA-focused AI platform. He is joined by co-founders Julian Weinstock, a technology leader with expertise in scaling SaaS products to $100M+ ARR, and Henry Kim, a MedTech commercialization veteran with 20+ years of experience launching and managing multi-million-dollar product portfolios. This team combines the domain expertise and technical know-how needed to disrupt the regulatory landscape.

Tier 1 Investor Lead - QMB’s $2.5M seed round is led by Bain Capital, with participation facilitated through The Boston Foundation’s healthcare innovation initiatives. This partnership stems from a joint growth fund aimed at empowering minority-based founders in Massachusetts. The fundraise will provide 18-24 months of runway, with breakeven expected in 16 months. The round has attracted significant interest, with additional soft commitments from respected institutional investors. Due to our close relationship with QMB’s CEO, we’ve secured priority access to this highly sought-after opportunity.

Full Deal Memo / Pitch Deck Here —>