About Us

FormlyAI is on a mission to make the medical device market accessible for startups across the world by making CE marking easy. We built software that makes MDR compliance feel second nature so that your device’s certification is straightforward with no uncertainty. Our solutions and support help all medical device companies achieve medical device certification in the EU and beyond.

Our Founders

Spencer Todd - CEO

Dr. Spencer Todd
CEO

After years of experience at the US FDA and working hands on to bring medical devices to market for small and large companies, Spencer knows best how to easily and quickly achieve regulatory compliance in the EU, US and abroad.

Severin Högl
CTO

Severin has experienced the difficulties of medical device CE marking firsthand, building and certifying a patient monitoring app. He has turned this expertise towards building software to make CE marking a breeze for other medtech companies.

Our Investors & Partners

Medical Device Certification Made Easy.