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Turn Complaints into Actionable Risk Intelligence : Intellirisk IQ

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Automatic AI assisted complaint categorization

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Automatic risk file calculations of occurrence, severity and risk levels with comparisons

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Ready to download reports in PDF and Excel!

🔍 Intelligent Complaint-to-Hazard Mapping


Automatically links complaint data to hazard profiles, enabling rapid identification of emerging safety signals and risk trends.

📊 Data-Driven Risk Insights


Integrates sales data with complaints to normalize event rates and prioritize risks based on real-world exposure.

⚡ Rapid Setup, Immediate Value


Upload your complaint workbook and hazard analysis file—IntelliRisk IQ begins processing instantly with no complex configuration required.

📁 Structured Risk Intelligence


Transforms unstructured complaint data into:

  • Hazard frequency/ severity trends

  • Risk signal detection

  • Benefit-risk context

  • Decision-support outputs

📈 Scalable for Post-Market Surveillance (PMS)


Designed to support:

  • ISO 14971 risk management

  • FDA signal detection expectations

  • EU MDR PMS / PSUR workflows

Check out all our solutions and offering here:

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