Formly.AI
Medical device conformity made easy.
| Date | Investors | Amount | Round |
|---|---|---|---|
| - | investor investor | €0.0 | round |
$2.0m | Early VC | ||
| Total Funding | 000k | ||
| USD | 2023 |
|---|---|
| Revenues | 0000 |
| EBITDA | 0000 |
| Profit | 0000 |
| EV | 0000 |
| EV / revenue | 00.0x |
| EV / EBITDA | 00.0x |
| R&D budget | 0000 |
Source: Dealroom estimates
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FormlyAI is a pioneering startup that simplifies the complex process of regulatory compliance for medical devices in the European Union (EU). The company offers an AI-driven, end-to-end solution to help medical device manufacturers navigate the intricate requirements for CE marking—a certification that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
FormlyAI primarily serves startups and small to medium-sized enterprises (SMEs) in the medical device industry. These companies often lack the resources and expertise to efficiently manage the regulatory landscape, which can be a significant barrier to market entry. By leveraging advanced artificial intelligence, FormlyAI provides a streamlined path to compliance, making it easier for these businesses to bring their products to market.
Operating within the medical device regulatory market, FormlyAI's business model revolves around a subscription-based software-as-a-service (SaaS) platform. Clients pay a recurring fee to access the software, which offers tools and support for achieving and maintaining compliance with the Medical Device Regulation (MDR) in the EU. The platform covers various aspects of the compliance process, including understanding regulatory requirements, obtaining CE marks, and managing unique device identifiers (UDIs).
FormlyAI generates revenue through these subscription fees, which provide clients with continuous access to the platform's features and updates. Additionally, the company may offer premium services such as personalized consulting and expedited compliance assistance for an additional fee.
In summary, FormlyAI is dedicated to making regulatory compliance accessible and straightforward for medical device companies, particularly startups and SMEs, by offering an AI-powered, user-friendly platform that simplifies the CE marking process in the EU.
Keywords: AI-driven, regulatory compliance, medical devices, CE marking, EU market, startups, SMEs, SaaS, MDR, subscription-based.