AI drafts the file. A credentialed MDR expert reviews and seals it. One flat fee.
The technical file is where good devices stall.
CE marking under the Medical Device Regulation hinges on one submission-ready technical file — and assembling it competes directly with building the product.
Complya is an AI-native regulatory service for small European medtech teams.
A first submission typically absorbs 200+ hours.
A handful of designated reviewers for a continent of devices.
Before a Notified Body even reaches your file.
A dozen-plus clinical, risk and post-market documents that must agree with each other and the device.
A non-conformity has no quick fix: the file rejoins the queue, and the months start again.
One governed system, from first upload to a living file.
The same verified facts flow through every stage. At each one, it's clear who is responsible — you, the AI, the rules engine, or your expert. Select a stage to see the hand-off.
Open a case for your device and answer only the questions it actually raises. Add the SOPs, certificates and test reports you already hold — each becomes a controlled, version-tracked source.
AI is only as good as the MDR expert behind it.
We pair credentialed MDR experts with purpose-built AI to make CE marking straightforward.
Credentialed experts + AI
Senior MDR experts shape every decision, so the AI applies their judgment consistently across every device.
Regulatory intelligence
Patterns across Notified Body decisions and MDCG guidance reveal what actually clears review, not just what the regulation says.
Device context
Each engagement deepens the system's understanding of your device, its class, its evidence, and its history.
Everything your Notified Body expects — drafted, checked and sealed.
The full technical file, not a template to fill in yourself.
The whole technical file
Every document your device class actually requires — device description, GSPR, risk, clinical, post-market, labelling and declaration — drafted as one consistent set rather than a template to fill in yourself.
AI-native drafting
The AI writes from your own evidence and cites each statement to its source. Nothing is boilerplate, and nothing becomes an authoritative fact until you confirm it.
One workspace with your expert
Open items route to whoever owns them: you answer what only the manufacturer can answer, your MDR expert reviews and seals, and the document updates in place.
Confidential by default
Your documents are hosted in the European Union, are never used to train shared models, and are visible only to your team and your assigned expert.
A file that stays true — long after it's sealed.
A CE submission isn't a one-time export. As your device, your evidence or the regulation changes, Complya keeps the technical file current, ties every sealed claim back to its source, and lets nothing reach your Notified Body without expert review.
Always current
Change a fact, a standard or the regulation, and every affected document flags itself for review. It can't be re-issued as current until your expert regenerates and re-seals it — so your file never quietly drifts out of date.
Traceable to the source
Each sealed document is locked to a tamper-evident record: the exact text, the evidence behind it, and who sealed it, when. Earlier versions stay on file for inspection — and none is ever shown as current once it's superseded.
Expert-sealed by design
AI drafts; a credentialed MDR expert reviews and seals. The regulatory rulebase they work from is itself approved by a second expert before it's ever applied — a two-person check on the rules, not only the documents.
Questions teams ask before they start.
Bring your device to market — without the documentation bottleneck.
Book a 30-minute demo. We'll map your device to its technical file and show you exactly what Complya delivers.