Flinn

What Flinn does

Flinn (legally 1BillionLives GmbH) is an AI-driven SaaS platform that automates regulatory and quality compliance processes for medical device manufacturers (MedTech) and pharmaceutical companies operating under EU MDR/IVDR and adjacent regulatory regimes. Founded in Vienna in 2022 by former N26 employees, the company sells a unified platform with five core modules — Safety Database Monitoring, Literature Evaluation, Regulatory Monitoring, Complaint Handling, and Vigilance — built on NLP, machine learning, and large language models that are fine-tuned on curated medical corpora and validated under IEC 62304 and ISO 13485. Flinn 3.0 (Nov 2025) added Clinical Writing, Citation management, and a Literature Library, and integrations with Mira.Digital (literature procurement) and Siemens Polarion (via avasis) extend the platform into adjacent enterprise systems.

The company serves a vertically segmented customer base spanning small and medium MedTech manufacturers (5–100 Technical Files) up through large enterprises with thousands of Technical Files, including named customers such as Erbe Elektromedizin, Skan AG, and Medi GmbH across 14+ countries in Europe and North America. Pricing is quote-based annual subscription, tiered by portfolio size and module selection, with a free demo / evaluation period reducing sales friction for smaller customers. Distribution is direct enterprise field sales supplemented by inside sales for mid-market and self-serve evaluation for smaller accounts, supported by a strategic advisor network of former executives from Siemens Healthineers, ResMed, Smith & Nephew, and DentsplySirona.

Flinn has raised approximately $30 million cumulatively across a December 2022 pre-seed (€1.8M, Speedinvest and SquareOne), a September 2024 seed (€10M, Cherry Ventures led), and a February 2026 Series A ($20M, HV Capital led with Bertelsmann Healthcare Investments and existing investors participating). The Series A is explicitly directed at US market entry and lifecycle expansion. The company operates from three offices (Vienna HQ, Berlin, Paris) with a headcount in the 11–50 band and is led by co-founders Bastian Krapinger-Rüther, Hasib Samad, and Markus Müller.

Name

Flinn

Legal name

1BillionLives GmbH

Website

https://flinn.ai

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Flinn is an AI-powered SaaS platform that automates regulatory and quality compliance workflows for medical device manufacturers and pharmaceutical companies, serving over 100 MedTech customers across 14+ countries with modules for safety database monitoring, literature evaluation, regulatory monitoring, and complaint handling.

Ownership category

akta.pro rank

Product category

MedTech Regulatory Compliance Software

NAICS

Scientific Research and Development Services (5417), Computer Systems Design and Related Services (54151)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pharmacovigilance & Drug Safety Software (HLAGAJAK)

akta.pro secondary industries

Regulatory Affairs & Submissions FSP (HLAGAOAD), Healthcare Outcomes & Real-World Evidence (RWE) Analytics (BPAHALAN)

Keywords

• Medical device compliance
• Regulatory automation software
• Clinical evaluation software
• Post-market surveillance
• MedTech AI platform

Headquarters

HQ city

Vienna

HQ country

Austria

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. SaaS Subscription: Cloud-based software subscription model providing access to the Flinn compliance platform, with modules for literature evaluation, safety database monitoring, regulatory monitoring, complaint handling, and vigilance management. Pricing is likely tiered based on portfolio size and number of modules.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Flinn provides an AI-driven SaaS platform that automates regulatory and quality processes for medical device (MedTech) and pharmaceutical manufacturers. Its modular suite covers safety database monitoring, literature evaluation, regulatory change monitoring, complaint handling, and vigilance management, with full validation documentation compliant to IEC 62304, ISO 13485, ISO 27001, EU AI Act, and FDA 21 CFR Part 11. The platform serves over 100 MedTech leaders across 14 countries, processing 40+ million publications and 20+ million incident reports.

Product overview

Flinn is an AI-driven platform for automating regulatory and quality processes in MedTech and Pharma. The platform follows a unified architecture with a core AI engine supporting multiple integrated modules: Safety Database Monitoring (vigilance), Literature Evaluation, Regulatory Monitoring, Complaint Handling, and a Vigilance Module. Flinn 3.0 introduced Clinical Writing, Citation, and Literature Library as sub-features. The platform automates workflows across the entire medical product lifecycle including post-market surveillance, literature reviews, regulatory compliance, and complaint management. Additional capabilities include a Word Plugin for document generation and API integrations with third-party systems like Polarion.

Differentiator

Problem solved

Functional benefit

Products and services

• Safety Database Monitoring AI-powered module that automates adverse event and safety database monitoring across 15+ global databases including FDA MAUDE, BfArM, and SwissMedic, with real-time vigilance surveillance, smart grouping of reports, automated de-duplication, and 1-click audit-ready report generation. Built for MedTech and pharmaceutical manufacturers under MDR/IVDR.
• Literature Evaluation AI-assisted literature search and screening module for systematic reviews, state-of-the-art searches, and PMCF/PMPF literature evaluation. Features multi-database search across 40+ million publications, human study detection with 99% precision, and integration with Mira.Digital for embedded literature purchasing.
• Regulatory Monitoring Module for monitoring and analyzing global regulatory changes and standards updates. Tracks changes to MDR, IVDR, FDA requirements, and other standards, with delta and impact analysis for regulatory compliance.
• Complaint Handling Module for managing complaint data intake, evaluation, and processing. Supports structured complaint workflows, intelligent categorization, and integration with risk management systems for MedTech compliance.
• Vigilance Module Comprehensive post-market surveillance module supporting PMS/PSUR reporting, PMCF/PMPF follow-up activities, and safety signal detection. Features automated monitoring, evaluation workflows, and audit-ready documentation with >80% faster vigilance processes versus traditional methods.
• Flinn Word Plugin Microsoft Word integration enabling direct literature report generation, citation management, and document writing within Word for regulatory and clinical writing teams.

Quantifiable outcome

• Complete vigilance process >80% faster than traditional methods
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability8 records

Feature8 records

Partnerships

Three partnerships are on record, tiered supporting and core.

• avasis solutions GmbHsupportingTechnology or Integration · 14 August 2025API integration partnership connecting Flinn with Siemens Polarion for streamlined MedTech regulatory workflows, enabling data exchange between quality management and regulatory compliance systems.
• MIRA.Digital GmbHcoreTechnology or Integration · 30 April 2025Integration partnership for literature procurement and license handling. Mira provides embedded purchasing and license management for scientific publications within Flinn's Literature Module, covering 99.9% of scientific publications worldwide with validated licensing compliance.
• qtec Services GmbHcoreStrategic or Co-development PartnerStrategic partnership providing MDR-compliant support in risk management, clinical evaluation, and regulatory affairs. qtec complements Flinn's platform with specialized consulting services throughout the medical device product lifecycle.

Scale indicators10 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Greenlight Guru: MedTech-focused quality management and regulatory compliance SaaS offering eQMS, CAPA, design controls, and document management — directly competes with Flinn's regulatory/quality automation platform for medical device manufacturers.
• MasterControl: Established QMS and regulatory compliance platform purpose-built for life sciences and MedTech, offering validated software for document control, training, and quality processes — overlaps with Flinn's validated compliance modules.
• Rimsys: Regulatory information management platform purpose-built for medical device companies, covering submissions, registrations, standards, and global regulatory intelligence — closely mirrors Flinn's regulatory monitoring and submissions support.
• Dot Compliance: AI-enabled QMS solution for MedTech and pharma covering complaints, CAPA, audits, and training — direct competitor in the AI-powered MedTech compliance category.
• Kneat: Digital validation lifecycle management SaaS for life sciences, used for equipment, computer system, and process validation — comparable to Flinn on the regulated validation/documentation layer of MedTech workflows.
• ArisGlobal: Life sciences regulatory technology platform covering regulatory information management, pharmacovigilance, and safety — overlaps with Flinn's vigilance and regulatory monitoring modules for pharma and MedTech.
• Schlafender Hase: Regulatory document validation and text-comparison software widely used in pharma/MedTech regulatory affairs — comparable to Flinn on regulatory submission accuracy and document proofreading use cases.
• AssurX: Regulated quality management software for life sciences including complaints, CAPA, change control, and audits — overlaps with Flinn's complaint handling and regulatory workflow automation.

Broad incumbents

• Veeva Systems: Large incumbent cloud software provider for life sciences with Vault RIM, Vault QMS, and safety modules — broader portfolio than Flinn but competes on regulatory document and quality management for MedTech/pharma.
• IQVIA: Global CRO and life sciences technology provider with regulatory affairs, safety/pharmacovigilance, and RWE services — competes indirectly through its tech-enabled regulatory and safety offerings for MedTech manufacturers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/flinn-ai

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds5 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Flinn