Complya produces your complete Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) technical file — clinical evaluation, risk management, post-market surveillance and more — reviewed and validated by credentialed experts. Flat fee. Submission-ready.
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.
The same process for every device. AI does the drafting; a credentialed expert does the signing.
Tell us what your device does and who it's for. Add any documents you already have — the AI reads them all.
The engine sets your risk class under Annex VIII, then drafts each document section by section — tracing every line to a source.
A credentialed Medical Device Regulation expert reviews every document, redlines what needs it, and signs off.
You receive the complete technical file, expert-signed and formatted for your Notified Body submission.
The full technical file, not a template to fill in yourself — grouped the way your submission is assessed.
Software leaves you to write it. Consultants advise by the hour. Complya produces the documents and includes the expert sign-off — for one flat fee.
Every document is reviewed and signed by a credentialed Medical Device Regulation expert. The AI assists — it never replaces the sign-off.
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.
Book a 30-minute demo. We'll map your device to its technical file and show you exactly what Complya delivers.