FormlyAI Raises $2 Million to Revolutionize Medical Device Compliance Using AI

FormlyAI, an AI-powered platform for medical device compliance, led by Dr. Spencer Todd and Severin Högl, has secured $2 million in seed funding led by Heal Capital with participation from Gradient, Massive Tech Ventures, Gaingels, and Mana Ventures. 

Medical device companies face steep regulatory hurdles, with certifications often costing hundreds of thousands of dollars and taking years to secure. More than 95% of startups lack in-house expertise to navigate this process. FormlyAI tackles this challenge with an AI-embedded platform combined with regulatory know-how, enabling companies to achieve certification 10x faster and at a fraction of the cost.

FormlyAI has already shown strong results, cutting quality and regulatory costs by an average of $70,000 and reducing time-to-market by up to six months. Its platform supports a broad range of medical technologies, from hardware devices to AI-driven software and complex systems.

Over the past year, FormlyAI has grown a strong client base across the EU and the US, including established consulting firms. Backed by both EU and US investors, the company is well-positioned in its core markets. With fresh funding, it plans to expand its team and scale operations, while targeting entry into Canada and Asia by year’s end.