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Why Formly

Capitalize on Market Opportunity

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.

Fastest Way to Market

Create your documentation at 10x the speed of traditional options with our intuitive AI-powered software.

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.

Export Support Included

Our weekly 1:1 expert support meetings and dedicated Slack or Discord channel with our experts ensures you’re always informed and on track for certification.

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

We know we have the back office covered with Formly. They are hands on and make our MDR compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.

Philipp Piroth

Co-Founder & CEO Myoact

I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience at Formly matched with their incredible software is an unbeatable combo.

Angela Frederickson

Sparq Compliance

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