We build you a roadmap that walks you through every one of your device's requirements so you have peace of mind from the beginning.
Your IVD Class - Covered
Get quick, proven compliance regardless of if you’re an IVD Class A, B, or C product
Get Perfect Clinical Performance
We guide you through clinical validation and performance evaluations so your device is accurate and audit proof
Expert Support So You're Never Lost
Our weekly 1:1 support 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
Loved it to
Philip Piroth
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