Flinn develops AI-based software that automates regulatory and quality processes in medtech, aiming to help manufacturers manage compliance more efficiently, reduce administrative workload, and support innovation across the medical product lifecycle.
Vienna-based Flinn, a provider of AI-powered software designed to automate regulatory and quality processes in medtech, has raised $20 million in additional funding. The round was led by HV Capital, with participation from US-based healthcare investor BHI – Bertelsmann Healthcare Investments, alongside continued support from existing investors Cherry Ventures, Speedinvest, and SquareOne.
The funding comes as healthcare systems globally face increasing pressure from ageing populations, more complex treatment approaches, and administrative challenges that are placing strain on public healthcare budgets. As costs rise, governments face growing difficulty managing expenditure, while patients may encounter reduced access to new treatments or higher out-of-pocket costs.
Medical devices and pharmaceuticals can improve efficiency through areas such as automated healthcare, advanced diagnostics, and personalised treatments. However, innovation in these sectors is shaped by strict regulatory and quality frameworks.
While these requirements are essential for patient safety, they can also extend development timelines and increase the costs of bringing products to market and maintaining compliance throughout their lifecycle. As compliance demands grow, many companies face rising operational complexity in managing regulatory and quality processes.
Flinn aims to address these challenges through AI-based software that automates regulatory workflows, data evaluation, and reporting, replacing manual, document-heavy processes with more scalable systems.
Bastian Krapinger-Rüther, Co-founder and Co-CEO of Flinn, said regulatory and quality requirements are increasingly contributing to costs across the medical product lifecycle.
Our software replaces manual, document-heavy workflows with automated systems that scale across products, markets, and regulatory regimes. This additional investment enables us to extend that infrastructure across more lifecycle stages and support manufacturers operating globally,
he added.
By integrating automation into regulatory and quality functions, the platform aims to help manufacturers improve operational efficiency, shorten development timelines, and maintain compliance while supporting patient safety requirements. The approach is intended to reduce administrative burden and allow teams to focus more on product development and innovation.
With the new funding, Flinn plans to expand its platform beyond existing regulatory and post-market solutions to cover earlier development stages as well as commercial processes, creating a unified compliance and quality framework across the full medical product lifecycle. The company also plans to use the funding to support international growth, including further expansion across Europe and entry into the US market.