Monterail and MAE Group Partner to Bring Regulatory and Commercial Expertise Into HealthTech Development

The partnership gives Monterail’s HealthTech clients direct access to MAE Group’s regulatory, clinical, and commercialization expertise.

NEW YORK, NY, UNITED STATES, October 6, 2026 /EINPresswire.com/ — Monterail, a software development company with 900+ products delivered globally, including 75+ healthcare products and 15+ regulated devices for clients like DocPlanner, Merck, Elvie, and Eargo, announced a partnership with MAE Group, a global medtech advisory and commercialization firm. MAE Group joins the Monterail HealthTech Universe, a partner network spanning regulatory, clinical, hardware, legal, and market-access expertise.

For clients, this means a single partner across the full healthcare product journey, from concept and development through regulatory clearance and commercialization. Monterail built the HealthTech Universe so clients don’t have to assemble that expertise piece by piece under deadline pressure.

“In regulated HealthTech, software is only one part of getting a product to market. Regulatory, clinical, and commercialization requirements are too often addressed only after core architecture decisions are made, which leads to redesigns and delays on the path to FDA clearance and market entry,” said Piotr Zając, HealthTech Director at Monterail. “Bringing MAE Group into the HealthTech Universe puts that expertise at the table while the product is still taking shape.”

Founded in 2013 and led by a CEO with more than 20 years in medical devices and commercialization, MAE Group reports a 100% regulatory success rate across the approvals it has managed, guiding products through FDA, ISO, and CE pathways for companies ranging from early-stage startups to blue-chip pharmaceutical corporations.

“A late regulatory finding can send a technically sound system back for redesign,” said Janet Kwiatkowski, founder and CEO of MAE Group. “Working with Monterail lets regulatory, clinical, and market requirements inform the critical decisions while there’s still room to act on them.”

About Monterail

Monterail is a software and product development company delivering custom web and mobile applications for fintech, proptech, HealthTech, and eCommerce. Since 2010, its 150+ experts have completed 900+ projects globally for brands including Bosch, EY, and SharkNinja. In HealthTech, Monterail combines product strategy, UX, and software engineering to build web, mobile, and regulated device software.

Companies building HealthTech products that need regulatory, clinical, and commercialization expertise alongside development can learn more about the Monterail HealthTech Universe: www.monterail.com/health

About MAE Group

Founded in 2013, MAE Group is a global medtech advisory and commercialization firm working at the intersection of regulated technology, clinical validation, and capital formation. The company supports medical device, in vitro diagnostic, SaMD, AI-enabled technology, and other digital health companies across regulatory and clinical affairs, quality systems, product development, due diligence, commercialization, financial strategy, and investor readiness.

To learn more about MAE Group’s regulatory and commercialization services, visit MAE Group: https://maegroups.com/

Marta Klimowicz
Monterail
+ +48 533 600 136
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MAE Group joins Monterail HealthTech Universe

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