Why Choose VigInfo CINA?

VigInfo CINA applies advanced AI to accurately and instantly assign IMDRF codes to incidents, helping manufacturers maintain compliance with global regulatory standards.

AI-Powered Analysis

Leveraging advanced natural language processing to extract key information from diverse sources, identify and evaluate incidents related to medical devices, VigInfo CINA automatically maps findings to the correct IMDRF codes across all annexes.

Input Flexibility

Supports both structured and unstructured data, including scientific publications, incident reports, emails, call transcripts, and free-text entries.

Regulatory Support

Helps manufacturers align with global regulatory frameworks and post-market surveillance requirements for medical devices.

Configurable Parameters

Analysis can be initiated via manual input or automated ingestion from a designated repository.

Efficient Workflow

Streamlines incident and adverse event identification and IMDRF code assignment, significantly reducing manual effort for regulatory and quality teams.

Resource Optimization

Minimizes the time and expertise required for correct coding while maintaining quality, repeatability, and a full audit trail for vigilance and post-market surveillance activities.

Our Solution

VigInfo CINA is purpose-built for medical device manufacturers, particularly Regulatory and Quality departments, to simplify incident detection and IMDRF code assignment.

1

Automated IMDRF Coding Across All Annexes

Ensures consistent global reporting, accelerates regulatory submissions, and reduces the risk of manual errors across all IMDRF annexes.

2

Real-Time Incident Trend Analysis

Continuously monitors changes in incident frequency and type, enabling manufacturers and regulators to detect emerging risks early, monitor post-market performance of devices, and prioritize corrective actions based on reliable data.

3

Flexible Input for Document Analysis

Supports automated ingestion from repositories, manual uploads in PDF or TXT format (e.g., journal articles, emails, call transcripts), or direct free-text input.

Features and Benefits:

  • Automated IMDRF Code Assignment
  • Multi-Format Input Support
  • Full Annex Coverage
  • Real-Time Coding & Reporting – instant code display in dashboard with filtering, sorting, and export options
  • Continuous Updates – always aligned with the latest IMDRF terminology releases
  • Regulatory Compliance Made Easy – ensures harmonized reporting across EU MDR, FDA, and other global frameworks
  • Time & Resource Efficiency – reduces manual workload and accelerates incident processing
  • Improved Accuracy – minimizes human error in code selection and classification
  • Enhanced Vigilance Intelligence – enables faster trend detection, root cause analysis, and early identification of recurring device issues
  • Flexible Integration – compatible with diverse document types and incident sources without requiring structured forms
  • Builds Trust – strengthens confidence with regulators, healthcare providers, and stakeholders

The VigInfo Advantage:

VigInfo CINA empowers medical device manufacturers to achieve consistent, compliant, and efficient post-market surveillance. By automating IMDRF coding, reducing manual effort, and providing real-time insights, it streamlines regulatory workflows, improves data accuracy, and supports proactive risk management – ultimately accelerating compliance, enhancing vigilance intelligence, and reinforcing trust with regulators worldwide.

Contact Us

Interested in learning more about how VigInfo CINA can streamline your IMDRF coding, enhance vigilance intelligence, and strengthen regulatory compliance? Get in touch with us today.

VigInfo AI s.r.o.

Příčná 1892/4

110 00 Praha 1 – Nové Město

Prague, Czech Republic

Company ID: 23181290

Company data box: zfq3dvw

This project is co-financed by the European Union under the NEXT GENERATION EU.