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. See emerging risk earlier. Act before it escalates.
See
every signal.
Regulatory databases. Adverse events. Recalls. Manufacturer complaints. Service and repair records. Procurement data. Device registries. Technical literature. The signals exist. We connect them.
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.
Get it to the right hands in time.
Hospitals see emerging device risks their vendors may have missed, before those risks escalate. Same intelligence engine. Two sides of the same safety problem.
From signals to action
One Platform.
Two Powerful Solutions.
One Device Safety Intelligence engine powers two purpose-built solutions,
one for manufacturers and one for healthcare organizations.
Minutes, not hours
Per complaint, end to end
100%
Reportability & death determination
313%
ROI vs in-house
75.8%
Cost reduction
Catch device risk before the recall
One safety picture, every source
Compare devices before you buy
Get alerted the moment risk rises
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.
Talk To UsRaw signals in.
Complaints, MAUDE, recalls, EHRs, claims, narratives - ingested at scale.
Domain-tuned models.
Trained on regulatory corpora, device taxonomies, and failure-mode ontologies.
Safety Graph.
A living device-safety knowledge graph grounds AI outputs in traceable evidence and regulatory context.
Multi-step reasoning agents.
Decompose every signal into jurisdiction-specific decisions: trend, signal, or reportable event.
Human-in-the-loop assurance.
ISO/TR 80002-2 based validation pathway. Every override strengthens the model. Auditable end-to-end.
Why Choose empowerreg?
Our Industry Focus
Hospital
Systems
Healthcare
Clinics
GPO & IDN
Networks
Payer
Organizations
Medical Device
Manufacturers
Regulatory &
Quality Consultants
Engineering
Design Firms
IVD Manufacturers
Regulation forces the rebuild. Infrastructure enables it. Demand pulls it through.
Regulatory forces
the Rebuild.
FDA's QMSR brings the U.S. quality framework into closer alignment with ISO 13485 and reinforces a risk-based quality-management approach. In parallel, EU MDR/IVDR is driving more rigorous lifecycle and post-market expectations.
Infrastructure
enables it.
The data fragmentation that blocked an intelligence layer for a decade is gone. Complaints, service logs, claims, EHRs and regulatory feeds can now be fused into a single evidence graph and reasoning agents can act on it.
Demand pulls
it through.
Manufacturers face a rebuild they can't defer. Hospitals, IDNs and GPOs are procuring against no real-world device intelligence layer at all. Both sides are moving at once.
empowerreg is an AI-native health safety intelligence company that turns real-world device data into risk decisions, sitting as an intelligence layer above your QMS rather than replacing it. It runs on one core engine: Safety Graph (a device-safety knowledge graph), Copilot (reasoning agents), and AI Foundry (federated fine-tuning that keeps customer data private).
CMPMS is empowerreg's manufacturer-facing first product, in revenue with multiyear contracts, running six modules: Complaint Handling, InteliRisk, SmartViz Analytics, Multi-regulatory PMS, Defensible Reporting, and CAPA Assist. It covers the full lifecycle, from pre-market hazard matrices through in-market complaints to postmarket technovigilance.
Safety Radar™ is empowerreg's emerging medical device safety intelligence platform for healthcare organizations. It is currently being developed with a select group of innovation partners.
Both sides of the device economy: sell-side manufacturers (regional exporters, multinational subsidiaries, enterprise medtech) and buy-side hospitals, IDNs, GPOs and procurement organizations. Consulting partners also deliver through a five-level model, from pilot proof to Safety Radar advisory.
Most tools just route the complaint and file the report; empowerreg answers the harder question: does this signal change the risk? Pilot results show 3.8 minutes per complaint, 12× analyst output, 80% lower cost and 90% faster hazard matrices, with one customer recovering $6M in EU market value.
empowerreg is designed for regulated enterprise environments, with configurable access controls, auditable workflows, validation support, secure cloud architecture and integration capabilities for existing quality and enterprise systems.
