Postmarket Surveillance

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The Adverse Events Reporting service helps organizations meet regulatory obligations by capturing, documenting, and submitting reports of product-related incidents to the appropriate authorities. We streamline the process by ensuring accurate data collection, timely submission, and compliance with FDA, EMA, and other global requirements. This service enhances patient safety, reduces regulatory risk, and provides transparency that strengthens trust in your products and brand.

Vigilance and Vigilance Reporting service ensures continuous monitoring of product performance and safety once devices are on the market. We help organizations capture, assess, and report incidents or adverse events in compliance with FDA, EU MDR, and other global regulatory frameworks. By managing vigilance reporting requirements, we support patient safety, maintain regulatory trust, and protect your brand through transparent, timely communication with authorities.

Field Actions and Corrections service provides rapid, compliant support when product issues require action in the market. We help organizations plan, communicate, and execute recalls, safety notices, and corrective measures in line with FDA, EU MDR, and other global regulatory requirements. By managing documentation, stakeholder communication, and regulatory reporting, we ensure swift resolution, protect patient safety, and maintain trust in your brand.

Our Complaint Handling service ensures that customer and product-related concerns are managed with accuracy, transparency, and full regulatory compliance. We capture, investigate, and document complaints in line with FDA, EU MDR, and other international standards, providing clear resolutions and timely reporting. By turning feedback into actionable insights, we help organizations strengthen quality systems, protect patient safety, and build lasting trust with clients and regulators.

The Recall – Removal or Correction service provides end-to-end support when products must be withdrawn or corrected in the market. We manage the process in compliance with FDA, EU MDR, and other global regulations, ensuring timely communication with regulators, customers, and stakeholders. From planning and documentation to execution and reporting, we help organizations minimize risk, protect patient safety, and maintain trust by handling recalls and corrections with precision and transparency.

The Postmarket Surveillance Plan service helps organizations design and implement structured monitoring programs to track product performance and safety after market release. We develop tailored plans in compliance with FDA, EU MDR, and other global regulations, ensuring systematic data collection, risk assessment, and reporting. By proactively identifying potential issues and documenting corrective actions, we support patient safety, regulatory compliance, and continuous product improvement thr