Request a Demo Customer Login
  • Home
  • Solutions
  • CMPMS

CMPMS™
Intelligence Platform

sg1

AI-Native Complaint Management
& Post-Market Surveillance

Turn fragmented complaint, adverse-event, risk, and vigilance data into connected regulatory intelligence, helping medical device and IVD manufacturers detect signals earlier, accelerate investigations, and maintain defensible global regulatory workflows.

Request Demo

  • AI-native safety intelligence

  • Continuous learning workflows

  • Multi-regulatory ready

  • Human-in-the-loop automation

empowerreg - A Healthcare Safety Intelligence Platform

We transform real world device data into actionable safety intelligence bridging compliance, risk, and decision-making across the device lifecycle.

Intelligence Layer

01
a

Sits above compliance and quality systems adds AI-driven analytics, signal detection, and risk harmonization that traditional EQMS cannot deliver.

Continuous Loop

02
b

Connects post-market complaints, adverse events, and real-world signals into a continuous feedback loop that evolves with your products.

Multi-Regulatory

03
d

Built for global post-market workflows across FDA MDR/QMSR, EU MDR/IVDR, Health Canada requirements, with IMDRF-aligned coding and harmonization.

We are not a compliance tool with analytics, we are an AI-native intelligence platform built for the new regulatory reality. We don’t replace your QMS. We make your post-market data intelligent.

CMPMS™ - Intelligent
Post-Market Surveillance

Under today’s QMSR, EU MDR/IVDR, and global vigilance requirements, fragmented post-market data can obscure emerging safety signals and burden regulatory teams.

b

Complaint Management

AI-driven intake, triage, investigation, MDR reportability with IMDRF coding and human-in-the-loop automation.

f

Reportability Decision Trees

Structured, defensible reportability workflows with automated decision trees for MDR, EU MDR vigilance, and Health Canada.

d

Global PMS & Vigilance

Multi-regulatory post-market surveillance and vigilance reporting: FDA, EU MDR, Health Canada, IMDRF.

secure

Risk Mapping & Analysis

AI-powered risk analysis for complaints and adverse events -dynamic risk profiling linked to product families.

g

Signal Detection & Trending

Emerging signal detection with trend analysis for complaints and risks across the device portfolio.

Icon

Report-Ready Assets

Auto-generated charts, tables, and graphics for PMS reports, PSURs, and regulatory submissions - export-ready.

c

Integration-Ready

Connects with existing QMS, ERP, and supply chain systems via open APIs - configurable SaaS architecture.

Outcome

Move from reactive compliance to proactive risk intelligence across every market you serve.

Data Privacy, Security & Governance

Built with enterprise-grade safeguards from day one - because your safety data deserves nothing less.

a

Data
Encryption

  • AES-256 encryption at rest,
    TLS 1.3 in transit.
  • Customer-managed keys available for enterprise tiers.
d

Fine-Grained
RBAC

  • Role-based access control at user, project, and module level.
  • Workspace isolation for multi-tenant deployments.
e

Privacy by
Design

  • GDPR-aligned.
  • PII handling and de-identification workflows built in.
b

Compliance
Frameworks

  • SOC 2 Type II aligned, ISO 27001 controls, ISO/TR80002-2, 21 CFR Part 11 ready audit trails and e-signatures.

Data
Residency

  • Regional hosting options to meet jurisdictional and customer-specific data residency requirements.
f

Governance
Framework

  • Audit logs, change management,
    version control, and full traceability across every workflow and decision

Quantifiable
Outcomes Across
Regulatory Operations

12x

Productivity analyst
output increase

10x

Reduction in
manual workflows

80%

Reduced
Operational Cost

$6M

Access to EU
market restored

90%

Faster Hazard
Matrix Creation

99%

QMSR-aligned complaint,
risk and post-market workflows