Want to CE mark your in vitro diagnostic (IVD) device?

Why Formly

Cover all EU IVDR requirements

Our software and regulatory affairs experts walk you through the process of covering every one of your device's requirements so you have peace of mind.

Your IVD Class - Covered

Get quick, proven compliance regardless of if you’re an IVD Class A, B, or C product.

Perfect Clinical Performance

We guide you through clinical validation and performance evaluations so your device is accurate and audit proof

Fastest Way to Market

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

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

Our expert guidance and intuitive software allow you to build and certify your device with unprecedented speed and clarity

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

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

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

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

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Ready to start?

Schedule a call with us to discuss your needs and see how our software works for you.

Frequently Asked Questions

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