Formly

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 Session

€0

HOW IT WORKS

Speak directly with our regulatory experts and get an honest assessment of your device classification, your pathway to market and exactly where you stand before you commit to anything.

    • No obligation to proceed

    • All discussed under NDA

    • Your IP stays yours

    Book a Discovery Call
    Dovetail

    Call for pricing of your classification

    HOW IT WORKS

    Everything from QMS implementation and technical file creation through to management of submissions and audits, clinical evaluation planning, post-market surveillance setup and multi-jurisdiction submissions run 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
      Dovetail
      QMS Plus
      Write the submission
      Yes
      Yes
      AI agent, trained for medtech
      Yes
      Yes
      Named senior lead, stays with you
      Yes
      No
      Money-back guarantee on clearance
      Yes
      No
      Startup-aligned pricing
      Yes
      Yes

      Not sure? Explore QMS Plus and Dovetail offerings further.

      Regulatory certainty when it counts

      Companies across markets trust Formly with their most complex, life-saving medical devices.

      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 Studies

      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

      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.

      Book a CallExplore Dovetail