SmartComplaints™

Powered by machine learning models on 6 million complaints, it will automatically categorize complaints according to MDCG-recommended IMDRF Adverse Event Terminology and FDA Event Types

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Discover how SmartComplaints can transform your complaint categorization process. Instant categorization of complaints according to IMDRF Annex A and E Codes and FDA Type.

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A categorization tool for medical device complaints

Proper categorization streamlines root cause analysis, improving efficiency and effectiveness of corrective actions.

Reduce non-compliance risk

Ensure Medical Device Coordination Group (MDCG) & IMDRF standards.

Global consistency

Facilitates standardized reporting across different markets, minimizing regulatory delays.

Accurate & efficient audits

Accurate use of IMDRF Annex codes improves traceability and simplifies the audit process.