Flinn, a Pan-European AI-powered regulatory and quality automation software company serving MedTech and Pharma, has received an additional $20 million in funding to expand automation across the medical and pharmaceutical product lifecycle. The round was led by HV Capital, with participation from US-based healthcare specialist BHI – Bertelsmann Healthcare Investments and continued backing from Cherry Ventures, Speedinvest, and SquareOne.
The Vienna-based company develops AI-enabled software designed to automate regulatory and quality processes, replacing manual, document-heavy workflows with scalable, intelligent systems. With this latest funding, Flinn plans to broaden its platform beyond regulatory and post-market functions to cover research and development, commercial, and post-market processes. The company also intends to deepen its footprint across Europe and enter the US market as it targets global demand for scalable, compliant, and cost-efficient healthcare innovation.
Healthcare systems worldwide are facing mounting pressure from aging populations, increasingly complex therapies, and administrative inefficiencies that are straining public budgets. While medical devices and pharmaceuticals play a central role in improving efficiency through robotized healthcare, advanced diagnostics, and personalized treatments, innovation in these sectors is constrained by stringent regulatory and quality requirements. These frameworks are essential for patient safety but often increase the cost and complexity of bringing products to market and maintaining compliance throughout their lifecycle.
Flinn aims to address these challenges by embedding automation directly into regulatory and quality functions. Its AI-driven software automates regulatory workflows, data evaluation, and reporting, enabling manufacturers to shorten development cycles while remaining compliant with safety standards. By turning compliance into a scalable infrastructure, the company positions regulatory operations as a competitive advantage rather than a bottleneck.
The platform is used by major MedTech companies, including Carl Zeiss, Philips, and Paul Hartmann, to manage regulatory complexity and maintain quality standards across global markets.
With the new capital, Flinn will introduce additional product capabilities earlier in the development cycle and extend automation into commercial processes, creating a unified compliance and quality backbone across the full product lifecycle. The expansion strategy is supported by HV Capital and Bertelsmann Investments’ global networks and industry expertise as the company scales across Europe and the United States.
