The regulatory platform you wish you had.

An AI agent trained on medtech regulation and an eQMS built by working RA experts who got tired of the tools available to them. It creates documents rather than storing them, connects to the tools you already use, and keeps you audit-ready.

Regulatory roadmap

Classification

Quality system

Technical file

Agent activity

Regulatory certainty when it counts

Trusted by some of the most complex device companies across markets.

Thank God we found Formly. They saved us 3-5 years by giving us the right advice and sparing us from having to navigate it all ourselves. They are true partners, not vendors. We truly feel they are here with us.

Christiaan FultonChromacare
View Case Study

Built by the people doing the work, for the people doing the work.

Whether you're a consultant managing multiple clients, a product team running compliance alongside development, or a director overseeing a portfolio, Formly replaces the tools that slow you down.

Product teams

Compliance that fits inside your existing workflow, rather than sitting outside it waiting to slow you down. Change management, ongoing compliance and direct integration with your development tools.

RA consultants

Quality-first document drafting and review, with a full audit trail for every edit. GDPR-compliant, transparent and built to meet the standard of scrutiny your clients will face.

RA directors

Portfolio-wide document management with standardised processes and global search across all your products. The visibility you need without the administrative overhead that usually comes with it.

A new generation of regulation software. Try it for free.

Formly Agent

An AI agent that knows regulation inside-out

Trained across global markets and connected to live regulation sources so it's never out of date without the hallucinations. Use in your browser or inside ChatGPT, Claude and your custom agents, fitting into the way you already work rather than asking you to change it.

  • Predicate search (FDA)

  • Device classification across jurisdictions

  • Document drafting and review

  • Gap analysis against ISO, MDR, FDA standards

  • Submission format checker

  • Built for team collaboration

Stylised image of prompting agent with complex use case
eQMS

An eQMS people actually use.

Not another document store. It creates documents, connects to your design files, captures change control properly and links every piece of evidence back to the standard it satisfies. Built by our ex-FDA RA team for working RA teams who have had enough of systems that create more work than they save.

  • Document control (ISO 13485-aligned)

  • Design file and DHF management

  • CAPA, complaint, and nonconformity workflows

  • Audit trail and e-sign

  • Port-out on exit, no lock-in

  • Migration in from Greenlight Guru, Qualio, Arena or any other eQMS

Stylised screen shot of a screen that makes the QMS look enticing

Built to do the work, not describe it.

Most platforms tell you what to do and leave you to do it. Formly does it with you.

Greenlight GuruQualioFormly
Write the submission
Advise only
No
Yes
AI agent, trained for medtech
No
Sometimes
Yes
Named senior lead, stays with you
Often churns
N/A
Yes
Money-back guarantee on clearance
No
N/A
Yes
Startup-aligned pricing
No
No
Yes

Pricing that fits where you are.

Whether you're evaluating the platform or running a full regulatory programme, there's a plan designed for your team size and stage.

30 Day Trial

€0

Put it to work on a real project, not a sandbox. Bring an active case, run it through the platform and see what your regulatory workflow looks like when the tools actually work.

WHAT'S INCLUDED
  • No credit card required

  • No obligations or pressure

  • Try before you buy

  • Product support

Start 30-day trial
Small-medium Business

€300/m

Connect to the tools your team already use and run your quality management the way it should always have been. A new generation of eQMS that fits around your workflow.

WHAT'S INCLUDED
  • First month free

  • Product support

  • No lock-in contract

  • Dedicated account manager

Get started today
Enterprise

Call for pricing for your organisation

Configured to your specific environment and scaled across your largest teams, with the customisation that makes adoption stick across a complex organisation.

WHAT'S INCLUDED
  • Custom implementation

  • Dedicated account manager

  • Top tier support

Want the right experts, not just the right software?

Formly QMS Plus gives you the tools to run compliance independently. But if you're navigating a new market, a new device class, or a submission you'd rather not own alone, Tandem puts a senior regulatory team in your corner. Same platform, with us doing the heavy lifting.

Frequently 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 Centre
GDPR
ISO 27001

Try it on a real case

The best way to evaluate a regulatory platform is to put real work through it. Start a 30-day trial and run one of your active projects through Formly. If it doesn't work for you, walk away with no strings attached.