EU MDR Compliance Made Simple

Revolutionary Regulatory Technology for Medical Devices

Transform your regulatory compliance with SmartRegulate - our AI-powered platform that automates EU MDR requirements, streamlines eQMS workflows, and reduces compliance time by 80%.

JD
John Doe
98.5%
EU MDR Compliance
+2.3%
24
Active Projects
+3
340h
Time Saved
+45h

Recent Activity

GSPR Checklist Generated
CardioGuard Pro • 2 hours ago
Completed
Technical File Review
NeuroStim Device • 4 hours ago
In Review

Compliance Trends

Jan
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Apr
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Jun
Live Demo

See SmartRegulate In Action

Watch how our revolutionary platform transforms regulatory compliance from weeks to minutes. Experience the power of AI-driven automation in medical device regulation.

SmartRegulate Platform Demo Thumbnail
3:04 minutes
Our Flagship Platform

Meet SmartRegulate

An advanced regulatory compliance platform for medical devices. Powered by AI, designed by experts, trusted by industry leaders.

Dashboard
eQMS
Compliance
Reports
SmartRegulate Dashboard Overview
Compliance Overview
98.5%
EU MDR Compliance
+2.3% this month
Active Projects
24
In Progress
+3 new projects
Recent Notifications
GSPR review deadline approaching for CardioGuard Pro
2h ago
Technical file approved for NeuroStim Device
4h ago
eQMS / Quality Manual / Document Control
Quality Management Procedures
Version 2.1 • Last updated 2 days ago
Approved
Risk Management Plan
Version 1.3 • Under review by Sarah Chen
Under Review
Design Control Procedures
Version 1.0 • Draft created 1 week ago
Draft

Document Workflow

1. Draft Creation
2. Technical Review
3. Quality Review
4. Final Approval

Compliance Status

ISO 13485
95%
EU MDR
88%
SmartRegulate Compliance Center
AI Device Classification
Completed
CardioGuard Pro
Class IIb Medical Device
Confidence
99.7%
GSPR Checklist
In Progress
78% Complete (47/60 requirements)
✓ General Safety Requirements
✓ Performance Requirements
⚡ Labeling Requirements
Regulatory Submissions
Clinical Evaluation Report
Under review by TÜV SÜD • Expected: April 2, 2025
Under Review
Post-Market Surveillance Plan
Preparation in progress • Expected: April 10, 2025
Pending
SmartRegulate Reports Dashboard
Compliance Report
94%
Project Timeline
Risk Assessment
Low Risk: 12 items
Medium Risk: 3 items
High Risk: 1 item
Our Services

Comprehensive Regulatory Solutions

From consulting to complete platform implementation, we provide end-to-end regulatory technology solutions.

Regulatory Consulting

Expert guidance on EU MDR compliance, regulatory strategy, and submission processes from our team of regulatory specialists.

  • EU MDR Gap Analysis
  • Regulatory Strategy Development
  • Technical File Preparation
  • Submission Support
Learn More

Custom Integration

Tailored integration solutions to connect SmartRegulate with your existing systems and workflows seamlessly.

  • API Development
  • System Integration
  • Custom Workflows
  • Training & Support
Get Quote
Get In Touch

Ready to Transform Your Regulatory Process?

Schedule a personalized demo and discover how SmartRegulate can revolutionize your compliance workflow.

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+1 (312) 319-1849
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Springfield, IL 62704