FormlyAI

FormlyAI positions itself as a virtual Chief Regulatory Officer, combining AI-driven software with human regulatory expertise to help medical device companies achieve certification and maintain ongoing compliance. Founded by Dr. Spencer Todd (CEO), who brings experience from the US FDA and medical device regulatory work, and Severin Högl (CTO), who has firsthand medical device certification experience, the company serves startups and emerging medtech companies.

The platform covers multiple regulatory frameworks including ISO 13485, FDA 21 CFR, EU MDR 2017/745, and IVDR 2017/746. FormlyAI's service model includes both pre-certification support (fixed fee) and post-certification ongoing compliance management (annual fee). The company provides a complete suite of regulatory services including Quality Management System implementation, technical documentation, clinical evaluation, risk management, post-market surveillance, and audit support through their electronic QMS platform.

FormlyAI has worked with over a dozen medical device companies across various product categories including implants, digital therapeutics, diagnostics, and AI-enabled health applications. The company has received backing from investors including Heal Capital, Gradient, MTV, Gaingels, Manaventures, and Founders Fund.

Choose FormlyAI when you need an all-in-one regulatory solution that eliminates the need to coordinate between multiple consultants, software vendors, and compliance specialists. The company excels in scenarios where startups want to move quickly to certification without building internal regulatory infrastructure, or when companies are entering medical device markets for the first time and need comprehensive guidance.

Expect a collaborative engagement model with a dedicated regulatory expert assigned to your account, supported by AI-driven documentation and workflow tools. The platform approach means you'll work within FormlyAI's established processes and templates rather than building custom compliance frameworks from scratch.

FormlyAI exclusively serves the medical device sector, providing specialized regulatory compliance services for health technology companies navigating FDA, EU MDR, and IVDR requirements. The company's healthcare focus encompasses the full spectrum of medical devices including physical implants, digital therapeutics, in vitro diagnostics, AI-enabled medical software, and consumer health devices.

Their expertise covers healthcare-specific regulatory frameworks such as ISO 13485 quality management, clinical evaluation requirements, medical device risk management (ISO 14971), and post-market surveillance obligations. The company demonstrates deep healthcare domain knowledge through work with fertility trackers, cancer diagnostics, patient monitoring apps, and other specialized medical technologies.

The ideal FormlyAI client is a venture-backed or bootstrapped medical device startup with 5-50 employees, developing Class I, II, or IIa/IIb devices, preparing for their first FDA or EU certification. These companies typically have strong technical and clinical teams but lack regulatory headcount, operate on lean budgets that favor fixed costs over hourly consulting, and value speed to market with predictable timelines.