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.
Classification
Quality system
Technical file
Trusted by some of the most complex device companies across markets.
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.
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.
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.
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.
Trained across global markets and connected to live regulation sources so it's never out of date without the hallucinations.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
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
Most platforms tell you what to do and leave you to do it. Formly does it with you.
Whether you're evaluating the platform or running a full regulatory programme, there's a plan designed for your team size and stage.
€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 INCLUDEDNo credit card required
No obligations or pressure
Try before you buy
Product support
€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 INCLUDEDFirst month free
Product support
No lock-in contract
Dedicated account manager
Configured to your specific environment and scaled across your largest teams, with the customisation that makes adoption stick across a complex organisation.
WHAT'S INCLUDEDCustom implementation
Dedicated account manager
Top tier support
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.
Some of the questions we hear most often. If yours isn't here, get in touch and we'll answer it directly.
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 CentreThe 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.
