Faster, lower-cost MDR/IVDR filings.
Fixed pricing only.
AI drafts the file. A credentialed MDR expert signs it. One flat fee.
The technical file is where good devices stall.
CE marking under the Medical Device Regulation hinges on a submission-ready technical file — hundreds of pages of clinical, risk and post-market evidence. For a small medtech team, assembling it is a quiet, expensive drag on the very people who should be building the product.
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.
Set up once
Create your organisation profile and open a case for the device. The platform asks only the questions your device actually raises — and skips the rest.
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.
Everything your Notified Body expects — drafted, checked and signed.
The full technical file, not a template to fill in yourself — grouped the way your submission is assessed.
Every claim traces back to its source.
Generic AI produces fluent text. Complya produces evidence. Select any sentence in a generated document and follow it to the exact source, the rule it satisfies, and the expert who signed it.
A file that stays true — long after it's signed.
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 signed claim back to its source, and lets nothing reach your Notified Body without expert sign-off.
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 It can't be re-issued as current until your expert regenerates and re-signs it — so your file never quietly drifts out of date.
Traceable to the source
Each signed document is locked to a tamper-evident record: the exact text, the evidence behind it, and who signed it, when. Earlier versions stay on file for inspection — and none is ever shown as current once it's superseded.
Expert-signed by design
AI drafts; a credentialed MDR expert reviews and signs. 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.
No hourly billing. Know your cost upfront.
One flat fee per device, agreed before we start. The full technical file, the expert sign-off and revisions within scope — all included. No surprise invoices, no meter running.
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.