Global Medical Device Company Manages Recalls with Smarteeva's Post-Market Platform

A leading global medical technology company required a robust recall management system that could handle multiple recalls, global affiliates, letter translations, notifications, and feedback collection. The company sold both large equipment and smaller distributor-sold equipment, making install base traceability a major challenge.

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Smarteeva's automated system empowered users to send 100,000+ notifications and collect more than 90,000 customer feedback responses.

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The Challenge

Spreadsheet-based recall management, complex translation workflows, no install base traceability

• Spreadsheet-based system was not sustainable and made FDA compliance very difficult
• All letters needed translation and localization with a complex workload management process
• Tracking install base was complicated with data spread across multiple CRMs
• Distributor-sourced install base information was almost non-existent

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How Smarteeva Solved It

Smarteeva partnered with the customer to design and deploy a purpose-built solution:

1. End-to-end automated recall process from issue identification through FSCA/C&R submission
2. Decision tree collecting statistically driven data to generate specific feedback forms
3. Automated stakeholder notification (customers, retailers, regulatory bodies)
4. Install base management system for exact device location tracing
5. Automated translation and localization technology for recall letters
6. Automated FSCA and C&R report generation for country-specific authorities
7. ERP integration for simplified notification lifecycle