01
One source for every filing
Approved product data feeds every jurisdiction. No parallel Word files per market.
Generate each filing from one product spine and track it in one place. Templates for EU MDR and FDA. Other markets from the same model.
Submission Management
Regulatory Jurisdictions Worldwide
Digitally submitted to your Notified Body
EU MDR dossier sent. They will come back with the assessment.
EU MDR
European Commission · 2017/745
Submissions
Available
See Details →
Templates
Available
See Details →
The outcome
This is what turns the platform from a document system into a market-access system.
Approved product data feeds every jurisdiction. No parallel Word files per market.
Track each submission from draft through review in a single place.
Exports and registrations stay linked to the governed model behind them.
How it works
Generate filings from one model, track them in one place, and keep every market linked to the same source.
01 Capability
Build and track submissions from the governed product model. One workflow per jurisdiction.
Submission Management
Regulatory Jurisdictions Worldwide
Digitally submitted to your Notified Body
EU MDR dossier sent. They will come back with the assessment.
EU MDR
European Commission · 2017/745
Submissions
Available
See Details →
Templates
Available
See Details →
02 Capability
See where every filing stands across markets, without chasing status in email threads.
Submission analytics
Sterilizator 20A · EU MDR
1. Device description
2. GSPR mapping
3. Risk management
4. Clinical evaluation
Benefit claim incomplete · jump to record
5. PMS plan
03 Capability
Generate jurisdiction deliverables from approved data, including EUDAMED-ready exports.
EUDAMED registration
Sterilizator 20A · XML from product data
Device / SPP upload
After Basic UDI succeeds
Related
Submissions sit on the same structured model. Open the sibling jobs or the enterprise path.
Next step
One product spine feeding EU MDR/IVDR, FDA 510(k), and beyond, tracked in one place.