Medtech Solutions

SmartBridge AI

AI-Powered Analysis
Regulatory Compliance
Smart Automation

Transform your medical device complaint handling with intelligent automation that understands, categorizes, and manages regulatory compliance.

At Collabridge, we developed SmartBridge AI to revolutionize complaint handling in the medical device industry. Our solution automates the end-to-end process — from initial categorization to reportability assessment and risk identification.

Automated Categorization
Risk Assessment
Compliance Management
98%
Accuracy
60%
Faster Processing
85%
Cost Reduction
Our Value Proposition

Why Choose SmartBridge AI

Unmatched Speed

Process thousands of complaints daily with automated analysis and categorization

Superior Accuracy

98% accuracy in complaint classification and reportability assessment

Regulatory Compliance

Built-in compliance with FDA, MDR, and other medical device regulations

Advanced AI

Powered by state-of-the-art NLP and machine learning models

Industry Challenges

Challenges We Solve

Manual Processing Delays

Traditional manual complaint handling leads to significant delays and backlogs

Our Solution

Automated processing reduces handling time by 60%

Inconsistent Classification

Human error and subjective interpretation lead to inconsistent categorization

Our Solution

AI-powered standardization ensures consistent classification

Regulatory Risk

Missing reportable events can result in serious compliance violations

Our Solution

Advanced detection ensures no reportable events are missed

Security & Compliance

Built-in Regulatory Compliance

FDA 21 CFR Part 11

  • Electronic Records Management
  • Digital Signature Compliance
  • Audit Trail Documentation
  • Access Control Systems

EU MDR

  • Post-Market Surveillance
  • Vigilance Reporting
  • Risk Management
  • Technical Documentation

Data Security

  • HIPAA Compliance
  • GDPR Requirements
  • Data Encryption
  • Secure Access Controls