Flinn

Flinn (Flinn.ai, operated by 1BillionLives GmbH) is a Vienna-based software company offering an AI-driven platform that automates regulatory and quality processes for medical device, IVD and pharmaceutical manufacturers. The platform centralizes data from multiple external and internal sources and automates work across four main solution areas: safety database monitoring, literature evaluation, regulatory monitoring, and complaint handling. It supports regulatory deliverables including post-market surveillance reporting (PMS/PSUR), post-market clinical and performance follow-up (PMCF/PMPF), and clinical evaluation and performance reports (CER/CPR), and is positioned to serve compliance with FDA, EU MDR, IVDR and other global requirements for low- to high-risk devices.

Functionally, the product provides one-click access to 15+ safety databases, real-time monitoring, automated de-duplication, market insights and one-click generation of audit-ready reports. It is designed for portfolios of any size, from SMEs to enterprises managing thousands of technical files, and integrates with existing quality management and regulatory systems. Flinn states it monitors and analyzes more than 40 million life science publications, more than 20 million incident reports, millions of complaints, and hundreds of global standards and regulations.

Following its February 2026 Series A, the company said it would extend the platform beyond regulatory and post-market workflows into earlier lifecycle stages such as pre-clinical data workflows and commercial processes, aiming to provide a single framework for compliance and quality across the medical product lifecycle.

Founding story

Press coverage reports Flinn.ai was founded in 2022; Vestbee names Bastian Krapinger, Rüther Markus Müller and Hasib Samad as founders, and Ventureburn identifies Bastian Krapinger-Rüther as Co-founder and Co-CEO.

Business model

Flinn sells its compliance automation platform to medical device, IVD and pharmaceutical manufacturers, offering modular solutions (safety database monitoring, literature evaluation, regulatory monitoring, complaint handling) plus add-ons such as literature purchasing licenses and a Microsoft Word citation plugin. Enterprise features including Clinical Writing and Flinn Cite are provisioned through direct contact with the company and customer success managers.

Software provided to manufacturers, with configurable literature license options for full-text access, including single licenses for one-time article access, shared floating licenses, and organization-wide global licenses.

Traction

Flinn states that 200+ MedTech and IVD companies use the platform across 14 countries, and that it monitors 40+ million life science publications, 20+ million incident reports, millions of complaints and hundreds of global standards and regulations. Reported customers include Carl Zeiss, Philips and Paul Hartmann. The company's press page states it secured €10m in less than 18 months as of its September 2024 seed announcement.

Latest developments

Flinn 3.0 launched on 26 November 2025 with Clinical Writing, AI Data Extraction, Flinn Cite, enhanced PRISMA diagrams and Regulatory Monitoring 3.0. In February 2026 the company announced a $20 million Series A led by HV Capital with participation from BHI – Bertelsmann Healthcare Investments and existing investors Cherry Ventures, Speedinvest and SquareOne, to be used for platform expansion across more lifecycle stages and international growth including US market entry.