The Smarteeva Solution

The Smarteeva Solution: Transforming Medical Device Post-Market Surveillance

Medical device complaints have increased 20% annually over the past 12 years. Recalls have risen 42% on average each year over the past five. Regulatory agencies on both sides of the Atlantic are tightening reporting requirements. Most PMS teams are still running on manual data entry, disconnected systems, and spreadsheet-based risk assessments.

Smarteeva was built to replace that entire patchwork with one connected platform where complaints, adverse events, recalls, risk files, and regulatory submissions share a single data model and a single AI engine. This overview covers the platform, the AI capabilities, the regulatory alignment, and the results from real customer deployments.

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What You Will Learn

This 3-page overview covers four areas. First, the four structural problems that make reactive PMS untenable at scale. Second, how Smarteeva’s six core products (Complaint Management, Adverse Events, Recall Management, PMS Reporting, Risk & CAPA, Product Registration) work together on one platform.

Third, the AI engine behind 96% first-pass extraction accuracy, 95% duplicate detection, and 8-minute PSUR generation, including Orchestra (no-code AI agent builder) and MDREngine (2.6M+ global safety records). Fourth, proof from deployments at companies managing 3M+ annual complaints, 100K+ recall notifications, and 300K+ MDRs.

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