Quality Assurance and Regulatory Affairs

Post-Market Surveillance

Maintain Compliance, Mitigate Risks

Stay compliant and confident in the ever-evolving global regulatory environment with our comprehensive Post-Market Surveillance (PMS) solutions for MedTech products. We help manufacturers meet regional and international post-market obligations, including FDA complaint handling, EU MDR post-market requirements, and other global standards. Our experienced team of clinical and regulatory experts ensures your devices remain safe and compliant throughout their lifecycle.

Post-market surveillance plays a critical role in maintaining medical device safety and performance once products are commercially available. Through proactive monitoring and ongoing performance evaluation, we help you safeguard reduce compliance risks and drive continuous product improvement.

Our Post-Market Surveillance Expertise

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Product complaint handling and vigilance reporting

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Post-market surveillance planning and execution: PMS Plans (PMSP) and PMS Reports (PMSR)

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Post-Market Surveillance (PMS) Trend Analysis and Reporting for Compliance

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Post-Market Clinical Follow-Up (PMCF)

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Periodic Safety Update Reports (PSURs)

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Corrective and preventive action (CAPA) management services

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Annual maintenance and regulatory reporting

Safeguard your devices with a proactive post-market strategy.