Medical DevicesPharmaceuticalRegulatory Information Management

AssurX Complaint Management Solution


Booth: 610

The AssurX Complaint Management Solution drives the fastest path to resolution with decision-tree methodology that automates from event intake through root cause analysis. regulatory reporting and investigations. Streamline reporting submissions with AssurX Medical Device Reporting (eMDR) for FDA MedWatch 3500A adverse event submissions. All MedWatch data is automatically formatted, validated and submitted to the FDA. AssurX also supports electronic report generation for EU, Canada other countries. Decision trees establish reporting deadlines to ensure the proper reports are submitted within required time frames based on country and type of incident. Additional reports can be generated from forms at any time, including Complaint Reports and Health Hazard Evaluations (HHEs). Create a closed-loop process for handling complaints.

Other product: The AssurX QMS Platform

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