FormlyAI has built an artificial-intelligence-driven platform that combines regulatory expertise with machine learning to guide medical device companies through complex certification processes. By automating traditionally manual tasks, the software enables clients to complete certifications up to ten times faster while saving an average of $70,000 in quality-assurance and compliance costs. Users also report reducing time-to-market for their devices by as much as six months, giving innovators a meaningful competitive edge. The platform serves a growing customer base across the European Union and the United States, including collaborations with established consulting firms. With more than 95% of medtech startups lacking in-house regulatory expertise, FormlyAI positions itself as a one-stop solution that eliminates the need for costly consultants and fragmented software tools. The company plans to expand its team and extend operations into Canada and several Asian markets by year-end, using new capital to support these initiatives. FormlyAI aims to become the industry standard for streamlined, affordable certification in the global medtech sector.

Total raised

$2M

Funding rounds

1

Latest round

Seed

Latest activity

Sep 2025