For Startups
I want a team to
run this for me.
You need senior regulatory leadership, but hiring a Chief Regulatory Officer is out of reach. We embed a team into yours and take you from pre-market to clearance.
You can't improve lives if you don't get to market
Formly is the regulatory partner for medtech companies who can't afford to wait. Built by medical device regulatory experts, you get senior ex-FDA experts who handle submissions, not just advise on them, a purpose-built eQMS, and AI agents trained on live regulation. Take us on as your full team or use the platform yourself. Either way, we'll shorten your path to approval.
Regulatory certainty when it counts
Companies across markets trust Formly with their most complex, life-saving medical devices.
Two ways to work with us
Whether you need a team to run regulatory for you, or better tools to run it yourself, Formly is built for both.
Global market access
Your path to global approval no longer requires different specialists for every jurisdiction.
- FDAFDA
- EU MDREU MDR
- EU IVDREU IVDR
- UKCAUKCA
- ISO 13485ISO 13485
- MDSAPMDSAP
Time for change
Regulatory work is stuck in the 1970s.
Medical devices have changed but the way we get them approved hasn't. Submissions still get written in Word, reviewed over email, and held up in back-and-forth with auditors. Meanwhile teams burn runway, founders burn out, and good devices miss their window.
QMS tools store documents but don't write them. General-purpose AI is smart but hallucinates and can't sit in your auditor meeting. The work still lands on someone's desk at midnight. We think that's worth fixing.
Everything you need in one place
An AI agent, an eQMS and senior regulatory experts as one team, or as a platform you run yourself.
Agents
An AI agent, trained on medtech regulation
Drafts, checks, explains, searches live regulation sources. Works in your browser, or inside Claude, ChatGPT and your tools via our MCP server. The agent does the tedious parts. You stay in the lead.
eQMS
An eQMS that gets used, not just filled
Built by working RA experts, for working RA experts. Creates documents, not just stores them. ISO 13485-aligned, audit-ready, migration-friendly in and out.
Dovetail
Embedded senior regulatory leadership
Ex-FDA experts and deep specialists across MDR, FDA, UKCA and MDSAP. Named leads, in-country in US, EU and Asia. Superpowered by our AI agent for unprecedented cost and time efficiency.
Pricing designed for every team size and stage, from early-stage startups to established regulatory teams.
Explore PricingFrequently Asked Questions
Some of the questions we hear most often. If yours isn't here, get in touch and we'll answer it directly.
Safe and secure
Your IP, design files and trade secrets are protected by full NDAs, ISO 27001-aligned security and comprehensive contracts, so you retain complete ownership of everything you bring to us.
Visit our Trust CentreGDPR
ISO 27001
Ready for market?
Let's start with a 30-minute discovery call. We'll tell you honestly whether we can help, and if so, what the shortest path looks like.
In good company
We work closely with leading medtech accelerators, industry associations and the investors backing the next generation of devices. That network is part of what you get when you work with Formly.
