Regulatory clearance is the last obstacle between a good medical device and the patients who need it. We started Formly because it was taking too long, costing too much and leaving founders to figure out a system designed against them.
Spencer came from the FDA. He had spent years on both sides of the regulatory process, watching brilliant devices get stuck in cycles of back-and-forth while founders burned through their runway and lost confidence in the path ahead. Severin had lived it as a founder himself, taking a patient monitoring app through CE marking and experiencing every frustration the process had to offer. Between them, they had the inside view and the outside view. They built Formly to fix both. Today Formly works with some of the most complex device companies across the US, EU and beyond, combining senior regulatory expertise, an AI agent trained on medtech regulation and a purpose-built eQMS into one team. The goal is the same as it was at the start: get more devices to the people who need them, faster.
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Founder
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.
LinkedIn profile
Founder
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.
LinkedIn profileAdvisor
After years of experience at the US FDA and working hands on to bring medical devices to market for small and large companies,
Advisor
After years of experience at the US FDA and working hands on to bring medical devices to market for small and large companies,
Advisor
After years of experience at the US FDA and working hands on to bring medical devices to market for small and large companies,
Formly is supported investors who understand what it takes to build in medtech.
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