Complaint Management Built for Medical Device Quality Teams

REMETREX PQMX is a connected complaint-management system.

The Complaint Management Challenge for Regulated Medical Device QA Teams

Medical device complaints can involve product configuration, lot or serial information, failure modes, user or patient impact, investigation requirements, and regulatory evaluation. REMETREX brings those activities into a connected complaint-management system.

  • The Ultimate Challenge

    A complaint can be the beginning of a larger investigation involving the device, product history, failure information, related complaints, reportability, and corrective or preventive activities.

  • Capture Complete Complaint Information

    Use structured intake to capture the information your organization needs to evaluate device complaints and determine the appropriate path.

  • Support Triage & Investigation

    Standardize assessment, prioritization, assignment, escalation, investigation, and documentation according to organizational procedures.

  • Connect Device & Complaint Information

    Organize product families, models, lots, serial numbers, components, failure modes, and related information as applicable to the organization’s process.

  • Support Regulatory Evaluation

    Document the organization’s reportability evaluation and related decisions in the complaint record.

  • Trend Complaint Data

    Evaluate patterns across products, device types, failure modes, geographies, complaint categories, and time periods.

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Maintain Traceability

Keep the complaint lifecycle connected from intake through investigation, evaluation, trending, and closure.

Built to Adapt

Start with a complete application and adapt the foundation to organizational terminology, workflows, data requirements, integrations, and reporting needs within the license and technical architecture.

Most quality leaders spend the first conversation trying to determine whether a new category is real or simply a pitch. Bring the hardest question. We will show you how the system and the model work.