Gather actionable insights to ensure a high level of product quality and patient safety
Insights to reduce product safety risk and ensure regulatory compliance
Improve the efficiency and effectiveness of post-market surveillance processes, including complaint handling and regulatory reporting. Take complaint handling capabilities to the next level with AI-augmented decisions using QualityWise.ai.
TrackWise Digital Post-Market Surveillance
Rapidly triage, investigate root causes and resolve complaints for continuous product quality improvements.
Stay on top of regulatory reporting requirements to ensure timeliness and accuracy of submissions.
Identify quality issues, find root causes and take corrective action to ensure safe and effective product is delivered to the customer and patient.
Key Capabilities for Post-Market Surveillance
Empower employees with a simple, intuitive interface to raise quality events anytime, anywhere – from their computer, tablet or smartphone.
Manage the entire complaint lifecycle—from investigation to resolution, and gain insights for continuous improvement.
Submit information to appropriate regulatory bodies with regulatory reporting capabilities like eMDR, EU MIR and adverse events.
View suggestions on type, reportability and severity, to help teams quickly triage and ensure timely action.
Identify related quality events and avoid repeating the same investigation multiple times.
Auto-categorization of complaints and quality event severity ensure timely action.