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Why Formly

Pay per Use

Don’t get weighed down by hefty licensing fees, only pay when you use your tools and not when they are running idle.

Customized Workflows

Tailored to your templates and preferences, our powerful AI tools integrate seamlessly into your workflows.

Harness the AI Advantage

Leverage the latest LLM models to give you and your team an unbeatable edge over your competitors.

Risk Management on Autopilot

Generate Preliminary Hazard Association (PHA) and Failure Modes Effect Analyses (FMEA) in seconds, tailored to your products.

Clinical Evaluations Just Easier

Supercharge the creation of Clinical Evaluation Plans and Reports using AI generated expert summaries, literature appraisals, equivalency tables, benefit risk analyses, and more.

Trusted by next-gen companies.

Why we are different

We use proven approaches that have passed audits and leading edge AI models to create an unbeatable match of efficiency and quality

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