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Turning device
safety signals into action before it's too late.

Every device related harm leaves a trail.
Complaints. Service logs. Claims. Adverse event reports. The signals exist.

For Device Makers For Health Systems
THE CATEGORY

Healthcare Safety Intelligence.

It's the layer the device safety system was missing - a continuous, AI-driven capability that
watches every signal source, separates pattern from noise, and routes what matters to the
people who can act on it. Not after the recall. Before.

001

See
every signal.

Regulatory databases. Manufacturer service logs. Hospital EHRs. Claims data. Complaint hotlines. Clinical narratives. The data exists. We bring it together.

002

Separate noise
from signal.

A purpose-built AI engine reasons across all of it – distinguishing a routine complaint from an emerging pattern from a reportable event. The kind of decisioning a general-purpose model can't do alone.

003

Get it to the
right hands in time.

Device makers catch their own signals before the recall. Hospitals catch what their vendors missed before harm reaches the patient. Same engine. Two sides of the same problem.

From signals to action

innovative solution

One Platform.
Two Powerful Solutions.

The same Healthcare Safety Intelligence engine drives two distinct go-to-market motions.
Both serve the same mission: intervene before harm cascades.

CMPMS

CMPMS™

CMPMS™ • For manufacturers

Catch your own signals earlier.

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Stay compliant across every jurisdiction. Innovate with confidence.

  • AI-driven complaint handling, triage, and IMDRF coding
  • Multi-regulatory PMS - FDA QMSR, EU MDR, Health Canada, IMDRF
  • Defensible, audit-ready reporting out of the box
"The Boston Scientific version of the Knepper story - prevented."
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Safety Radar

Safety Radar™

Safety Radar™ • For health systems

Catch what your vendors missed.

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Procure on real-world evidence, not vendor claims.

  • Cross-vendor safety signals, aggregated across global sources
  • Recall intelligence and brand-comparison harm summaries
  • Threshold-based escalation alerts for procurement and clinical teams
"The Gladys Knepper version - her hospital sees the signal first."
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The shared engine

Same engine underneath. Every deployment makes it smarter.

THE TECHNOLOGY

Not a workflow tool with AI bolted on. A reasoning system, purpose-built for device safety.

empowerreg connects and analyzes data across multiple sources to deliver real-time safety intelligence.

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001

Raw signals in.

Complaints, MAUDE, recalls, EHRs, claims, narratives - ingested at scale.

002

Domain-tuned models.

Trained on regulatory corpora, device taxonomies, and failure-mode ontologies.

003

Safety Graph.

A living knowledge graph the models reason against so the AI grounds in evidence, not hallucination.

004

Multi-step reasoning agents.

Decompose every signal into jurisdiction-specific decisions: trend, signal, or reportable event.

005

Human-in-the-loop assurance.

ISO/TR 80002-2 validated. Every override strengthens the model. Auditable end-to-end.

Why Choose empowerreg?

  • Comprehensive PMS System with TPLC Support
  • Audit Support – Our software assurance & validation
  • State-of-the-Art Risk Management
  • Improve Accuracy & Compliance Confidence
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  • Accelerated Decision-Making
  • Accelerated Global Market Access
  • Speeds Up Time-to-Market for New Product Launches
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Our Industry Focus

Medical Device Manufacturers

In Vitro Diagnostic Manufacturers

Regulatory & Quality Consultants

Engineering Design Firms

Medical Device & IVD Startups

Hospitals, Clinics & Healthcare Networks
PROOF IT WORKS

Already saving market access. Already preventing the next recall.

Aseptico - a $24M dental equipment manufacturer was facing $7M in losses and the loss of its EU market.

"It did what our team cannot do — and saved us major dollars in loss of market access."
- Aqualizer View Case Studies

10×

Reduction in manual workflows

$6M

EU market access restored

99%

EU-MDR & QMSR ready out of the box

CUSTOMER SUCCESS

Reduced complaint review
time by 90%.

NovaPharm — a growing pharmaceutical manufacturer was struggling with recurring audit findings and increasing regulatory pressure.

"What normally takes multiple teams and weeks of preparation was completed in a fraction of the time."
- Head of Quality Systems View Case Studies

90%

Reduction in review time

3x

Faster signal detection

100%

Audit readiness

Our Customers
and Strategic Partners

THE MOMENT

Three forces converged in 18 months.
The window is open.

Regulation forces the rebuild. Infrastructure enables it. Demand pulls it through.

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Regulatory Rebuild

Regulatory
Rebuild.

FDA's Quality Management System Regulation harmonizes U.S. device requirements with ISO 13485. EU MDR enforcement is tightening in parallel. Every manufacturer's postmarket workflow is being rebuilt right now.

Infrastructure Unlock

Infrastructure
Unlock.

FDA's March 2026 Adverse Event Monitoring System consolidates seven legacy databases into one real-time platform. The fragmentation that blocked a resilience layer for a decade is gone.

Demand Pull

Demand
Pull.

Value-based care now requires hospitals and payers to demonstrate evidence-based, safety-informed purchasing. Vendor claims aren't defensible anymore. The buy-side is waking up just as the sell-side is forced to rebuild.

FAQ

Frequently
Asked Questions

empowerreg is an AI-powered healthcare safety intelligence platform that transforms safety signals into actionable insights.

CMPMS centralizes post-market surveillance workflows and simplifies compliance management.

Safety Radar provides cross-vendor safety intelligence for healthcare systems.

Medical device manufacturers, hospitals, consultants, and healthcare networks.

Automated workflows and AI-driven intelligence reduce manual effort and reporting risk.

Yes. Built for enterprise-scale deployments with secure and compliant infrastructure.