Vienna-based startup Flinn.ai, which uses AI to automate regulatory and quality compliance for medical device companies, has raised a $20 million in a Series A funding round, led by HV Capital to drive global expansion, including further growth in Europe and entry into the US market.
- Founded in 2022 by Bastian Krapinger, Rüther Markus Müller, and Hasib Samad, Flinn.ai develops AI-driven software to automate regulatory and quality compliance processes for medical device companies. The platform enables manufacturers to manage portfolios of devices, from low- to high-risk, and ensures compliance with MDR and IVDR requirements.
- Flinn.ai works by collecting and centralizing data from multiple sources, automating tasks such as post-market surveillance, literature evaluation, regulatory monitoring, and complaint handling.
- The system generates audit-ready reports, monitors safety databases in real time, and integrates with existing quality management and regulatory systems, allowing teams to reduce manual work, shorten evaluation cycles, and maintain full compliance throughout the product lifecycle.
- In 2024, the firm raised €6 million in a seed round to advance AI-driven solutions for MedTech compliance and quality. The round was led by Cherry Ventures, with participation from existing investors Speedinvest and SquareOne Venture Capital.
Details of the deal
- The Series A round was led by HV Capital, with participation from BHI – Bertelsmann Healthcare Investments, and continued support from existing investors Cherry Ventures, Speedinvest, and SquareOne.
"We’ve backed the Flinn team since day one – and they keep raising the bar. What started as a bold vision is now a mission-critical platform for leading MedTech organizations worldwide. Flinn is building a scalable, AI-driven system across the entire product lifecycle, rapidly expanding beyond regulatory and quality automation. Excited to welcome strong partners for this next chapter of building a global AI powerhouse out of Vienna," claims Andrea Zitna, Partner at Speedinvest.
- Flinn will use the $20 million in fresh funding to expand its AI platform across more stages of the medical product lifecycle, automate additional regulatory and quality workflows, and support international growth, including further expansion in Europe and entry into the US market.
