28 Maynew devices
28 Novlegacy
Pricing

Register every device.
Nothing rejected.missing.

Daiki reads your documents and prepares every mandatory
EUDAMED field. You review and approve — on your terms.

0
DAYS
:
0
0
HRS
:
0
0
MIN
:
0
0
SEC
Don't have an SRN yet?
The problem
You already know this work.
The document hunt
Digging through PDFs to find one value. Every field needs a source — IFU, CE cert, tech doc, label.
The scale
Doing it across every device, every variant. Same work, different values, multiplied.
The never-ending cycle
It's not a one-time project. New PRRC, renewed cert, updated IFU — changes keep coming.
Manual
6 - 8 weeks
With consultant
4 - 6 weeks
With Daiki
2 hours
How it works
You do two things. Daiki does the rest.
Between your upload and your sign-off, the agent does everything else.
You
1
Upload documents
IFUs, CE certs, tech docs, labels — drop them in.
2
Review exceptions
Resolve only what the agent flags. Approve and sign off.
EVERYTHING IN BETWEEN
AI Agent
Reads every page
OCR, tables, figures — nothing missed
Classifies documents
IFU, CE cert, tech doc — auto-detected
Extracts fields
Every value cited to document, page, section
Cross-validates
Checks consistency across all sources
Packages XML
Batched, pre-validated, submission-ready
Monitors ongoing
Certificate expiry, PRRC changes, EMDN updates
AI Agent
Documents to EUDAMED. One agent.
Upload your documents. The AI Agent reads, extracts, validates, packages, submits, and monitors — end to end.
1
SRN
2
Upload
3
Process
4
Review
5
Package
6
Monitor
Step 1: Enter your SRN
Your Single Registration Number identifies your organisation in EUDAMED.
MF
Manufacturer
You design and manufacture the device
AR
Authorised Rep
You represent a non-EU manufacturer
IM
Importer
You place non-EU devices on the market
e.g. BE-MF-000012345
Continue
Your Company Name
Manufacturer · PRRC, Notified Bodies, and address verified
SRN verified against EUDAMED. Proceeding to document upload.
Enter your manufacturer SRN. Daiki cross-checks it against EUDAMED actor records.
Why Daiki
Built by AI governance leaders
Daiki is ISO 13485 certified and works with regulated organisations on ISO 42001, ISO 27001, and the EU AI Act.
ISO 13485ISO 42001ISO 27001EU AI ActAIMS
ISO quality-managed development
We understand medical device quality processes from the inside. Daiki is built the same way.
MDR compliant
Built against Annex VI, Decision (EU) 2025/2371, and XSD v3.0.25.
Full audit trail
Every value links to document, page, and section. PRRC-verifiable.
Your documents are protected
Encrypted, never used for AI training, and deleted after processing.
AI Management System
ISO 42001-aligned AIMS governs how our AI reads, extracts, and validates your data.
The deadline is real. Daiki can help.
Upload your documents today. Every mandatory EUDAMED field — sourced, cited, and submission-ready.
View pricing