Formly

You feed Formly details about your medical device and your company, and it helps produce the documentation regulators expect, with AI drafting the writing and a library of tools for managing those files over time.

Formly is a medical device compliance software platform that guides certification in the EU and US, with a focus on startups trying to reach market quickly and on a budget.

The standards coverage is specific: MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304 and IEC 62366.

That spans quality management, risk management, software lifecycle and usability engineering, which are the areas small device teams tend to struggle with first.

Expert regulatory guidance sits alongside the AI-backed documentation writing, so you are not left to interpret the rules alone.

This is a narrow tool.

If you are not building a regulated medical device, Formly has little to offer.

If you are, it is a focused way to organize and write your compliance paperwork.