Flinn
Flinn.ai is an AI-driven platform designed to automate regulatory and quality processes within the MedTech industry. It caters to low to high-risk medical devices and can manage portfolios of any size, from SMEs to enterprises with thousands of Tech Files. The platform focuses on enhancing efficiency by enabling smarter monitoring across multiple databases, faster AI-assisted evaluations, and one-click audit-ready reports. Key features include automated complaint data handling, safety database monitoring, literature evaluation, regulatory monitoring, and post-market surveillance reporting (PMS/PSUR), post-market clinical/performance follow-up (PMCF/PMPF), and clinical evaluation/performance reports (CER/CPR). Flinn.ai is trusted by over 100 MedTech leaders and is tailored to MDR/IVDR requirements, adhering to standards like IEC 62304, ISO/TR 80002-2, ISO 13485, ISO 27001, ISO 14971, and FDA 21 CFR Part 11.
Flinn
Flinn.ai is an AI-driven platform designed to automate regulatory and quality processes within the MedTech industry. It caters to low to high-risk medical devices and can manage portfolios of any size, from SMEs to enterprises with thousands of Tech Files. The platform focuses on enhancing efficiency by enabling smarter monitoring across multiple databases, faster AI-assisted evaluations, and one-click audit-ready reports. Key features include automated complaint data handling, safety database monitoring, literature evaluation, regulatory monitoring, and post-market surveillance reporting (PMS/PSUR), post-market clinical/performance follow-up (PMCF/PMPF), and clinical evaluation/performance reports (CER/CPR). Flinn.ai is trusted by over 100 MedTech leaders and is tailored to MDR/IVDR requirements, adhering to standards like IEC 62304, ISO/TR 80002-2, ISO 13485, ISO 27001, ISO 14971, and FDA 21 CFR Part 11.
TL;DR
Headquarters: Vienna, Austria
Founded: 2022
Product: AI platform to automate regulatory and quality processes for medical device manufacturers
Employees: About 41 (source snapshot)
Recent funding: Seed round Sep 30, 2024 (€6,000,000 recorded)
Company Overview
Problem Domain
Regulatory compliance, quality management, and post-market surveillance for medical devices
Founded
2022
Industry
Medical / Medical Devices; RegTech/MedTech software
Funding Track Record
€6,000,000
Crunchbase records list ~29 investors participating, including multiple angel/individual investors.
Investor Signal
“Seed round led by Alexander Weber with participation from numerous angels/individual investors (~29 participants)”