FormlyAI raises $2M led by Heal Capital to revolutionize medical device compliance using AI

New capital to accelerate US market expansion, scale EU operations, and further develop its AI-powered platform that has already saved clients an average of $70K and reduced time-to-market tenfold.

CHARLESTON, September 11, 2025 – FormlyAI, the only AI-native solution for medical device certification, today announced the closure of a $2M seed funding round. The round was led by Heal Capital with participation from Gradient, Massive Tech Ventures, Gaingels and Mana Ventures. The investment expedites FormlyAI’s mission to simplify and automate the complex regulatory landscape for medical device companies globally.

Every medical device company faces a significant hurdle: navigating the intricate and ever-evolving web of regulatory requirements. Getting a certification to allow the sale of a medical device traditionally costs companies hundreds of thousands of dollars and can take years. On top of that, over 95% of startups lack any in-house expertise on how to do it. FormlyAI has combined their novel AI-embedded platform with regulatory expertise to accelerate companies through certification at 10x the speed at an affordable price.

"Certification is the universal challenge every medical device company must overcome, yet it's the burden no one wants to bear," said Dr. Spencer Todd, Co-Founder and CEO of FormlyAI. "Companies must choose between expensive consultants or software with piecemeal solutions. Instead we've built FormlyAI to be the one-stop-shop for our clients, leveraging an AI-driven platform along with deep industry expertise to deliver certification with efficiency not seen before. This funding enables us to support more innovators to bring their life-changed devices to market. Certification is no longer the elephant in the room”

FormlyAI has already demonstrated significant impact, saving an average of $70,000 on quality and regulatory expenditures and decreasing time-to-market in some cases by 6 months. The platform supports a wide array of medical technologies, including hardware products, AI-driven software, and complex system products. 

“Medical certification is one of those painful admin processes that companies must go through to place the product in the market. But it doesn’t have to be - that’s why we’ve decided to back FormlyAI, which uses AI to lower barriers to expertise and allows companies to do certification faster and cheaper.” said Marta Mrozowicz from Heal Capital. “We’ve been impressed by the team’s comprehensive understanding of the problem and the market. We’re excited to be leading this round and back a solution that can enable faster innovation for the entire medtech industry.”

"FormlyAI's innovative approach to a deeply entrenched industry problem is exactly what we look for," said Andrew Brackin at Gradient. "Their ability to combine AI with regulatory expertise to deliver tangible results, like reducing time to market by 10x, showcases their potential to become the industry standard. We are thrilled to support their expansion and continued product development."

In the past year, FormlyAI has built a robust client base, now serving clients across the EU and US, including serving established consulting firms. The company's strategic use of EU and US investors is key to effectively managing and growing in these primary markets. With the new funding, FormlyAI plans to expand its team, adding new members to support its growing operations. Furthermore, the company is set for ambitious growth, with planned expansion into Canada and Asian markets by the end of this year.

About Formly: Formly lets anyone certify their medical device without needing in house regulatory expertise. AI-embedded software alongside regulatory experts ensure medical devices are certified in record time at a fraction of the cost. The company is fully remote based in the United States and Berlin, Germany. Formly was founded in 2023 by regulatory expert Dr. Spencer Todd, formerly at the US FDA, and medical device founder Severin Hoegl, formerly of comjoodoc. For more information, visit https://www.formly.ai/.   

About Heal Capital: Heal Capital creates a partner ecosystem for best-in-class access to the healthcare market. We are backed by leading private health insurers and engage with our innovation council to solve the largest challenges in healthcare. Heal Capital is headquartered in Berlin, Germany. For more information, visit https://www.healcapital.com. 

About Gradient: Gradient has been investing at the forefront of artificial intelligence since 2017. We are led by former founders, technical experts, and domain specialists who have supported hundreds of AI founders from the beginning. Gradient is headquartered in San Francisco. For more information, visit www.gradient.com. 

About Massive Tech Ventures: Massive Tech Ventures is an early-stage venture fund founded by Stefan Kalb and Eric Woersching. We take concentrated early positions in opportunities that are sector- and geography-agnostic, focusing on world-class founders tackling massive opportunities. MTV is based in Seattle and to contact us go to mtv.vc.