Run your entire post-market
safety operation on one platform.
An AI-native core for Complaint Handling, Risk Management, and PMS - expert-level determinations at platform speed, across QMSR, EU MDR, and IMDRF.
Book a demoThe platform at a glance
One operation
Complaints · Risk · PMS
Per complaint, end to end
Minutes, not hours
Reportability & death
100% agreement
Regulatory frame
QMSR · EU MDR · IMDRF
Your whole safety
operation, under one roof.
Complaint Handling
Intake, triage, MDR reportability and IMDRF coding - human in the loop.
Risk Management
InteliRisk profiling across complaints and adverse events, with faster hazard matrices.
Post-Market Surveillance
Trending, multi-regulatory PMS reporting and PSURs across QMSR, EU MDR and IMDRF.
Measured on degraded
data - not a forecast.
Minutes, not hours
Per complaint, end to end
100%
Reportability & death
99.5%
Injury determination
95.4%
Malfunction determination
99.1%
VOC categorization
On ambiguous IMDRF coding, human reviewers agreed only 56 - 71%, the engine stayed consistent. Figures from pilot data, not guaranteed outcomes.
From backlog and lost market access to compliant and current.
Mid-size device manufacturer
Facing $7M in losses, including blocked EU access, the team moved its safety operation onto empowerreg.
12×
Analyst output
80%
Lower operational cost
$6M
EU market access restored
90%
Faster hazard matrix
1
Platform, not a tool stack
One engine,
many regulators.
Report-ready output
QMSR · EU MDR · Health Canada · IMDRF
The same core maps to each framework - no separate process per region.
Audit-ready by design
Evidence and a human on every call
Every determination is traceable and reviewer-signed - inspection-ready.
Put your post-market operation on one AI-native platform.
We'll run it against a sample of your own complaints.