FormlyAI

Pricing for every stage and organisation

Transparent, milestone-based pricing with no hourly billing and no opaque retainers. Whether you need a full regulatory team or a platform to run it yourself, there is a plan built for where you are.

Free Discovery

€0

WHAT'S INCLUDED

  • Ask our regulatory experts

  • Advice on device classification

  • Know where you stand

  • No obligation to proceed

  • All discussed under NDA

  • Your IP stays yours

Book a Discovery Call
Regulatory Strategy

€3,000

WHAT'S INCLUDED

  • Device classification

  • Regulatory roadmap

  • Clinical evaluation planning

  • Fixed pricing

  • Costs absorbed if continuing with VCRO

  • Apply for grant valued at €3,000

Book Regulatory Strategy
VCRO

Call for pricing

WHAT'S INCLUDED

  • Clinical evaluation planning

  • QMS implementation

  • Technical file creation

  • FDA process management

  • Post-market surveillance setup

  • Multi-jurisdiction in parallel

  • Fixed pricing

  • Milestone-based payments

  • Money-back guarantee

Book a Discovery Call

Compare our products

Not a consultancy. Not just software. Three ways to work with Formly. Use one, or combine them as your needs grow.

FEATURE
TandemQMS PlusAgent
Write the submission
Yes
Yes
Yes
AI agent, trained for medtech
Yes
Yes
Yes
Named senior lead, stays with you
Yes
Yes
Yes
Money-back guarantee on clearance
Yes
Yes
Yes
Startup-aligned pricing
Yes
Yes
Yes

Not sure? Explore QMS Plus and Tandem offerings further.

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
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