Tandem is an alternative to the consultant path. You get a senior regulatory expert embedded into your team, backed by our AI agent and purpose-built eQMS. We write the submissions, sit in the auditor meetings and stay with you until your device is approved. Full regulatory leadership, without the cost of a full-time hire.
Most founders face the same three options when it comes to regulatory. None of them are good enough on their own
Trusted by some of the most complex device companies across markets.
Human expertise at the helm, AI doing the work it's actually good at, and an eQMS that keeps everything audit-ready. One team, yours.
The numbers behind the founders who chose the shortest path.
80+
Successful certifications
100%
Audit success rate
5x
Faster submissions
€70K
Average avoided costs
Your path to global approval no longer requires different specialists for every jurisdiction
Used by our own regulatory experts on the most complex cases every day, so by the time it gets to yours, it's road tested where it matters.
Your team and our AI agent working in the same place, on the same documents, in real time. No version control headaches, no emailing attachments and no wondering who has the latest file.
Not a consultancy. Not just software.
Priced for runway, not billable hours. Milestone-based payments, rear-loaded terms, and no payment at all if your device doesn't clear. Here's how most founders start.
€0
HOW IT WORKSSpeak 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
€3,000
HOW IT WORKSA full regulatory roadmap covering your device classification, pathway to market & clinical evaluation plan.
Apply for regulatory strategy support valued at €3,000
Fixed pricing
Costs absorbed if continue with VCRO
Everything from QMS implementation and technical file creation through to FDA process management, clinical evaluation planning, post-market surveillance setup and multi-jurisdiction submissions run in parallel.
Fixed pricing
Milestone based payments
Money-back guarantee
Working with Tandem typically involves five core stages. These aren't always strictly sequential and often run in parallel, because regulatory clearance rarely moves in a straight line. Find your path to approval.
Book a Discovery CallIdentify the ideal pathway for your device
eQMS setup, SOPs, and training
Feature sets under design control
Test with efficiency and confidence
We're in the meeting and you pass.
If you've got the expertise in-house and just need a better platform to run it through, Formly QMS Plus has you covered.
Here's some common questions we get, if you've got one that's not here feel free to get in touch.
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 CentreStart with a 30-minute discovery call. We'll tell you whether Tandem is right for you and, if so, what the shortest path to clearance looks like. No sales pitch, no obligation, and everything discussed under NDA.
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.
