# FormlyAI

Startup profile on Capital Atlas: https://capitalatlas.ai/startups/formlyai

- Industry: Software
- Headquarters: US
- Website: www.formly.ai
- Total disclosed funding: $2M
- Latest round: Seed (Sep 11, 2025)
- Investors on record: 5

## About

FormlyAI Inc. is a US-based company specializing in regulatory compliance services for medical device manufacturers, harnessing both artificial intelligence and human expertise to navigate complex regulations effectively.FormlyAI Inc. was founded in 2021 in the United States, focusing on providing regulatory compliance services for medical devices. The company successfully raised USD 2.000 mn in Seed funding on September 15, 2025, led by Heal Capital, with participation from Gradient Ventures, Gaingels, Mana Ventures, and Massive Tech Ventures Management. The founder's history and prior ventures are currently not disclosed.FormlyAI provides a comprehensive suite of regulatory compliance services specifically designed for medical device companies. Their core offerings include regulatory documentation, certification strategy, audit support, and ongoing compliance management, all powered by a combination of artificial intelligence and human expertise. The platform assists clients in navigating complex regulations such as ISO 13485, 21 CFR, MDR 2017/745, and IVDR 2017/746, ensuring that medical devices meet necessary compliance standards. FormlyAI serves a diverse client base that includes startups and established companies across various sectors such as digital therapeutics, cancer diagnostics, and implantable devices. Their services are tailored to fit different stages of product development, making them relevant in markets including North America, Europe, and potentially other global regions where medical devices must adhere to stringent regulatory requirements.FormlyAI operates on a revenue model that includes both pre-certification and post-certification services, structured around fixed fees for their regulatory support packages. Clients engage with FormlyAI through a subscription-based model that offers varying levels of compliance management, from self-managed to fully outsourced services. Revenue is generated by providing tailored solutions for medical device certification, ongoing compliance needs, and training programs for client teams. The comprehensive nature of their offerings allows for predictable pricing that aligns with the specific needs of clients, thus facilitating smooth business transactions. Key services include annual fees for ongoing compliance support and dedicated regulatory expertise, designed to ensure that clients remain compliant without burdening their internal resources.In September 2025, FormlyAI Inc. raised USD 2.000 mn in Seed funding to support its expansion plans. The company intends to utilize this funding to enhance its service offerings and explore new market opportunities. Specific goals include the development of new products tailored to evolving regulatory standards and expansion into additional geographic regions, although the exact markets have yet to be detailed.

## Funding rounds

- Seed, Sep 11, 2025, $2M — Gaingels, Gradient Ventures, Heal Capital, Mana Ventures, Massive Tech Ventures Management

## Investors

- Gaingels (https://capitalatlas.ai/funds/gaingels) — Seed
- Gradient Ventures (https://capitalatlas.ai/funds/gradient-ventures) — Seed
- Heal Capital (https://capitalatlas.ai/funds/heal-capital) — Seed
- Mana Ventures (https://capitalatlas.ai/funds/mana-ventures) — Seed
- Massive Tech Ventures Management (https://capitalatlas.ai/funds/massive-tech-ventures-management) — Seed