Get to market, then stay compliant
- from day one.
One AI-native platform for the whole lifecycle: pre-market submissions
to get you cleared, and post-market safety to keep you there
- before you build a quality team.
The platform at a glance
Covers
Submission → surveillance
Live markets
empowerreg reg experts
Stand up in
Days, not quarters
Regulatory frame
QMSR · EU MDR · IMDRF
Strategy & Classification
The fastest compliant route to market — risk class and rules under FDA and EU MDR.
Risk Files
FMEA and ISO 14971 hazard matrices by product family, ranked from real field failure modes.
Submissions
510(k), De Novo and PMA dossiers, with predicates and rationale backed by real device history.
Complaint Handling
Intake, triage, MDR reportability and IMDRF coding - with a human in the loop.
Risk Management
InteliRisk profiling across complaints and adverse events, with fast hazard matrices.
Post-Market Surveillance
Trending, PMS reporting and PSURs across QMSR, EU MDR and IMDRF.
No department
to build
Ship a compliant program before you can afford a full RA/QA team.
First complaint
to full portfolio
The same core carries you from first submission through commercial scale.
Begin small,
grow as you go
Stand up on a pilot and expand as volume and portfolio grow.
We'll run the engine across your pipeline, from filing to the field.
