Transforming Medical Device Post-Market Surveillance

In the last decade, medical device complaints have increased 20% annually. Recalls have risen 42% on average each year. High-profile cases like the Philips CPAP recall have put complaint management under intense regulatory and public scrutiny. EU MDR has tightened reporting obligations. FDA is pushing for real-world evidence and earlier risk detection.

Most PMS teams are caught in the middle: running on manual processes, disconnected systems, and narrowly focused on compliance rather than safety intelligence. This white paper examines the structural problems in current PMS operations and shows how Smarteeva addresses each one with integrated risk management, AI-powered complaint intake, automated regulatory reporting, and a global safety data lake.

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What You Will Learn

Where PMS teams are stuck: why 80%+ of staff time goes to data collection instead of risk assessment and product improvement. Why risk management rarely integrates with complaint handling due to organizational silos and QMS limitations. How self-service capabilities for customers and field teams represent a missed opportunity for structured data capture.

How Smarteeva solves each problem: integrated risk management with FMEA scoring, smart complaint templates with 96% extraction accuracy, similar record functionality for faster decisions, automated MDR/PSUR/PMSR generation, and MDREngine’s 2.6M+ global safety records for benchmarking and signal detection.

Key Data Points

20% annual increase in medical device complaints over 12 years. 42% average annual increase in recalls over 5 years. 70% faster complaint resolution on Smarteeva. 96% first-pass extraction accuracy. 95% duplicate detection rate. 8-minute PSUR generation. 3-minute MDR submission. 35% of FDA MDRs filed through Smarteeva. 1 in 5 FDA recalls managed on the platform.

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