Flinn AI

Flinn AI builds software that uses AI to automate regulatory and quality processes for medical device manufacturers. Its platform covers literature evaluation, safety database monitoring, regulatory monitoring and complaint handling. Teams can search multiple databases, evaluate evidence with AI assistance and generate reports supporting post-market surveillance and clinical evaluations. It accommodates portfolios ranging from small businesses to enterprises managing thousands of technical files.

Founded in 2022 by Bastian Krapinger-Rüther, Hasib Samad and Markus Müller, Flinn is led by co-CEO Bastian Krapinger-Rüther. Its engineering work includes FLARE, a risk-based method for validating AI in regulatory affairs. The framework connects intended use, vendor assessment and feature-level risks with test sample sizes and expert review; it is a practical method, not a regulatory standard. Flinn also developed EvidenceStream with Erbe, using screening and extraction agents to structure clinical evidence from scientific literature.

As of August 2026, the company reported that 200+ MedTech companies relied on Flinn. It raised a $20 million Series A in 2026 led by HV Capital, with participation from BHI, Cherry Ventures, Speedinvest and SquareOne. The financing supports planned expansion into more stages of the medical product lifecycle and international growth.