Flinn is an AI‑driven platform that automates regulatory and quality processes for medical device manufacturers. It continuously monitors and de‑duplicates data from over 15 safety, literature, and regulatory databases, linking findings to each device’s technical file and providing real‑time dashboards, AI‑assisted evaluations, and one‑click audit‑ready reports to streamline post‑market surveillance and ensure MDR/IVDR compliance.
Funding
$6.7M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
2OFounders
Product
Problem
Medical device manufacturers must continuously monitor vast amounts of safety reports, scientific literature, regulatory updates, and customer complaints to stay compliant with MDR and IVDR. Manual tracking across dozens of databases is time‑consuming, error‑prone, and costly, especially for organizations managing large portfolios of devices.
Solution
Flinn provides an AI‑driven platform that automates the collection, de‑duplication, and analysis of safety database entries, literature publications, regulatory changes, and complaint records. The system continuously scans more than 15 external databases and millions of documents, applying natural‑language processing to extract relevant information and map it to each device’s technical file. Users can access real‑time monitoring dashboards, generate audit‑ready reports with a single click, and receive AI‑assisted evaluations that highlight compliance gaps and emerging risks. By centralizing these processes, Flinn reduces manual effort, accelerates post‑market surveillance activities, and helps manufacturers maintain MDR/IVDR compliance across portfolios of any size.
Target Audience
Flinn is aimed at regulatory affairs, quality, and clinical teams within medical device companies that need to manage post‑market surveillance and compliance for multiple products.
Features
- Automated monitoring of 15+ safety, literature, and regulatory databases with one‑click access
- Real‑time AI‑powered de‑duplication and relevance scoring of incident reports and publications
- Integrated complaint handling workflow that links adverse events to specific device records
- One‑click generation of audit‑ready reports for PMS, PSUR, PMCF, and clinical evaluation submissions
- Dashboard visualizations of market insights, trend analyses, and compliance status
- Scalable architecture supporting portfolios from SMEs to enterprises with thousands of tech files