Devices

Comprehensive Device Solutions

Integrated
tools for compliance, and monitoring

End-to-End Regulatory Solutions

Complete Compliance Tools for Devices

From signal detection to regulatory intelligence, our suite ensures seamless compliance management for medical devices.

IMDRF

Automated IMDRF Coding

Streamline Complaint Management with Accurate IMDRF Code Mapping

Accelerate complaint processing with AI-powered IMDRF coding, ensuring real-time accuracy, compliance with global regulations, and seamless integration into quality management systems for medical devices.

BioMed Literature

Automated Device Literature Monitoring

Extract device safety insights from global literature sources

The BioMed Literature Platform automates the process of identifying device-related complaints from scientific and medical literature. It removes duplicates, generates custom reports, and ensures compliance with device-specific reporting requirements, streamlining device surveillance.

Signals

AI-Powered Signal Detection

Identify and manage device safety signals with precision

The Signals Platform employs advanced AI algorithms to detect, evaluate, and monitor safety signals for medical devices in real-time. With workflow automation and actionable dashboards, it enables proactive risk management and ensures compliance with global regulatory standards.

RegIntel

Regulatory Intelligence for Devices

Stay ahead of device safety regulations worldwide

RegIntel provides real-time updates and insights on device-specific regulatory requirements across 65 countries. With AI-powered search, tailored reporting, and intuitive dashboards, it simplifies compliance management and enables informed decision-making for medical device safety.