- Flinn secures an additional $20 million to expand AI-driven automation across the medical and pharmaceutical device product lifecycle
- The round is led by HV Capital, with participation from US based healthcare specialist BHI - Bertelsmann Healthcare Investments and existing investors Cherry Ventures, Speedinvest and SquareOne
- Funding will support product expansion from R&D to post-market processes, as well as international growth across Europe and the US
Flinn, the leading provider of AI-powered software for automating regulatory and quality processes in MedTech, today announced that it has received $20 million in additional funding. The round was led by HV Capital, followed by US based healthcare specialist BHI - Bertelsmann Healthcare Investments with continued support from existing investors Cherry Ventures, Speedinvest, and SquareOne.
With the new funding, Flinn will expand its platform across the entire product lifecycle in MedTech and Pharma covering research and development, commercial and post-market processes. The company will also deepen its presence across Europe and enter the US market, addressing the global need for scalable, compliant, and cost-efficient healthcare innovation.
Addressing exploding healthcare costs through automation
Healthcare systems worldwide are under immense pressure. Aging populations, increasingly complex therapies, and administrative inefficiencies are pushing public healthcare budgets to their limits. Governments are struggling to absorb these costs, while patients face the growing risk of reduced access to cutting-edge treatments or higher out-of-pocket expenses.
Medical devices and pharmaceuticals play a critical role in bending this cost curve through robotized healthcare, advanced diagnostics, and personalized treatments. However, innovation in these sectors is constrained by some of the most stringent regulatory and quality requirements of any industry. While essential for patient safety, these frameworks often slow down innovation and significantly increase the cost of bringing products to market and sustaining compliance across their entire lifecycle.
This is precisely where Flinn creates impact.
Efficiency and innovation through automating compliance
Flinn is transforming how regulated MedTech and Pharma companies manage quality and compliance. Its AI-driven software automates regulatory workflows, data evaluation, and reporting. This way, manual, document-heavy processes are replaced by scalable, intelligent systems.
By embedding automation directly into regulatory and quality functions, Flinn enables manufacturers to operate more efficiently, shorten development cycles, and remain fully compliant without compromising patient safety. What was once a bottleneck becomes a competitive advantage, allowing teams to focus on innovation rather than administration.
Today, leading MedTech companies such as Carl Zeiss, Philips or Paul Hartmann rely on Flinn to manage growing regulatory complexity while maintaining the highest quality standards across global markets. “At Paul Hartmann, Flinn has fundamentally changed how we approach regulatory and quality work,” said Stefan Fischer, Senior VP Regulatory Affairs at Hartmann. “By automating recurring compliance and evaluation tasks, our teams can operate more consistently across markets and focus on higher-value activities that require expert judgment. This level of scalability is becoming essential as regulatory requirements continue to grow in both scope and complexity.”
Strategic expansion across the product lifecycle
With the additional $20 million in funding, Flinn will develop new product capabilities beyond its existing regulatory and post-market solutions. The company will apply automation to earlier development stages and commercial processes, creating a unified compliance and quality backbone throughout the entire lifecycle of a medical product.
This expansion is paired with international growth, leveraging the deep industry networks and global experience of HV Capital and Bertelsmann Investments to scale Flinn’s impact across Europe and the United States.
Quotes
Founder quote “Regulatory and quality processes have become one of the main cost drivers across the medical product lifecycle. Our software is designed to replace manual, document-heavy workflows with automated systems that scale across products, markets, and regulatory regimes. Being able to utilize this additional product investment enables us to extend that infrastructure across additional lifecycle stages and support manufacturers operating globally,” said Bastian Krapinger-Rüther, Co-Founder and Co-CEO of Flinn.
HV Capital quote “Flinn combines exceptional commercial traction with best-in-class customer feedback and a compelling product vision that immediately resonates with technology investors. Above all, it is the team’s ability to move with speed and conviction, while remaining deeply committed to the medtech customers they serve and the global impact of their work, that sets them apart. We are thrilled to lead the company into its next chapter,” said Felix Klühr, General Partner at HV Capital
Bertelsmann Healthcare Investments quote “In Flinn, several factors came together that made us particularly excited at BHI. Bastian brings hands-on experience in MedTech, while Markus and Hasib have demonstrated their ability to build regulated products at impressive speed. We invested in Flinn because we are convinced that MedTech teams deserve a true user-first system of action, and Flinn is uniquely positioned to build it. There is a clear whitespace in the U.S. market, and we are eager to partner closely with the team to help them break through and scale in the U.S.” said Tim Schneider, Partner at BHI
About Flinn
Flinn is a Pan-European software company building AI-powered solutions to automate regulatory and quality processes in MedTech and Pharma. By transforming compliance from a manual cost center into a scalable knowledge hub, Flinn helps manufacturers innovate faster, operate more efficiently, and deliver safe, high-quality healthcare products globally.
About HV Capital
HV Capital is one of the leading early-stage and growth investors in Europe. With nine fund generations in 25 years and €2.8 bn in managed assets, HV Capital is one of the continent's most active investors. The investment team has many years of experience in identifying European startups with great potential for success. In addition to international success stories like Flix, Zalando, Delivery Hero, Sumup, and Depop, innovation leaders such as Quantum Systems, Marvel Fusion, Sennder, Neura Robotics, Enpal, and Isar Aerospace are also part of the portfolio. HV Capital has invested in more than 250 internet and technology companies, supporting startups with ticket sizes ranging from €0.5m to €60m. It is one of Europe's few venture capital firms that can finance startups through all growth phases. HV Capital has a team of more than 60+ investment and operations professionals who provide a variety of perspectives and expertise across the venture capital landscape.
About BHI - Bertelsmann Healthcare Investments
BHI is an independent, financial-first transatlantic healthcare-focused investment firm. BHI is backed by Bertelsmann Investments, Bertelsmann's global investment arm with >$2 bn AUM. Headquartered in New York and with an European Office in Berlin, BHI partners with entrepreneurs from day one to early growth, supports its companies throughout their lifecycle and has the flexibility and long-term conviction to double or even triple down in the later stages. For European and Israeli founders, BHI is often the first point of contact in the U.S.
Contact:
Markus Müller
Flinn, Co-Founder & Co-CEO
markus(at)flinncomply.com
Kasey Davies
VP Marketing at HV Capital
kasey.davies(at)hvcapital.com
Maximilian Boner
BHI, Europe Lead
max(at)bhi.vc