Acces one of the largest markets in the world to take your business to new heights.
Your Submission Type - Covered
Whether you are 510(k), 510(k) exempt, De Novo, or PMA, we can support you through FDA approval.
The Fastest Way to Market
Create your documentation at 10x the speed of traditional options with our intuitive AI-powered software.
Expert Support So You're Never Lost
Weekly 1:1 support with FDA experts including ex-FDA staff on our team ensure you are compliant and on track.
Transfer Your Existing Data
Existing clients can transfer their existing data for EU MDR in our system towards their FDA submission to make the process even faster and easier.
Trusted by next-gen companies.
Why we are different
Medical device compliance is Formlys core competence. We know what founders need and have helped bring dozens of device to market.
The most revolutionary
We have an unbeatable combo: a team of premier regulatory experts paired with a revolutionary AI-powered software.
The most tech-forward
We leverage the most advanced LLMs and eQMS tools so that your quality and regulatory lifecycle is a works for you, not the opposite.
The most startup friendly
We are the last regulatory resource you’ll need. We have helped a ton of company’s devices across the finish line and as your needs evolve, we’ve got you covered.
What our customers are saying
Loved it to
Philip Piroth
Our package with Formly is exactly what we wanted and what we needed — no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that’s what you really need.
Anina Langhans
Co-Founder & Product Lead LipoCheck
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