Post-Market Surveillance

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. 

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TrackWise Digital Post-Market Surveillance

 
 
Continuous Quality Improvement

Rapidly triage, investigate root causes and resolve complaints for continuous product quality improvements.

 
 
Effective Global Regulatory Reporting

Stay on top of regulatory reporting requirements to ensure timeliness and accuracy of submissions.

 
 
Ensure Customer Satisfaction and Patient Safety

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

 
 
Intake

Empower employees with a simple, intuitive interface to raise quality events anytime, anywhere – from their computer, tablet or smartphone.

Complaint Handling

Manage the entire complaint lifecycle—from investigation to resolution, and gain insights for continuous improvement.

Regulatory Reporting

Submit information to appropriate regulatory bodies with regulatory reporting capabilities like eMDR, EU MIR and adverse events. 

AI-enabled Complaint Categorization

View suggestions on type, reportability and severity, to help teams quickly triage and ensure timely action. 

AI Insights

Identify related quality events and avoid repeating the same investigation multiple times.

Early Risk Detection

Auto-categorization of complaints and quality event severity ensure timely action.

Let’s talk about how our solutions can work for you

Request a demo to learn more about how TrackWise Digital post-market surveillance can meet your organization’s needs.