Post Market Surveillance & Vigilance

Patient safety, regulatory compliance, and customer satisfaction are top priorities for every life science company, and you want to provide the best possible products to customers. As business goes global and distribution increases, ensuring quality and compliance requires more rigorous post-market surveillance. That’s where we come in.

It’s your responsibility to monitor the safety and efficacy of your products after they go to market and we can help. ECI provides robust support for post-market surveillance, including end-to-end complaint management, regulatory/vigilance reporting (MedWatch forms, MIR, etc.), and thorough communication with the appropriate health authorities. 

Our team has extensive experience managing product quality complaints across a wide range of therapeutic areas and various digital platforms. We can also help with the filing of regulatory documents (surveillance plans and reports, clinical and performance follow-ups, periodic safety updates), conducting health hazard evaluations (HHEs), and managing device recalls.

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By the Numbers

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Our Capabilities

Global PMS Strategy

Complaints Handling

Medical Device Reporting (MDR) / Vigilance Reporting​

Field Corrective Actions: Recall Strategy and Execution

Post-Market Clinical Follow-up (PMCF)

Post-Market Surveillance Plan and Report (PMSP and PMSR)

Periodic Safety Update Report (PSUR)

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients through post market support? Find insight on how we support customers through case studies specific to post market surveillance and vigilance.

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Our Strategic Services

Looking for support outside of regulatory compliance? Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Let Us Help

You focus on your business. We focus on the momentum of the industry and help you keep pace across your portfolio.

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