Smarteeva Streamlined Product Registration for a Global Medical Technology Company

A global medical technology company manufacturing both diagnostic and therapeutic products needed a streamlined digitized system for product registration, status tracking, expiration date management, and country requirement groups, all in a single application.

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Smarteeva simplified the end-to-end registration process by integrating with the company's ERP system, saving time, resources, and cost.

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The Challenge

Spreadsheet-based registration tracking, no cross-linked documentation, no global visibility

• Multiple spreadsheet systems with no cross-link to documentation and country templates
• Tracking individual product expiration dates without unified automation was complex
• Managing registrations, licenses, and regulatory impact assessments across global portfolio in one application was unthinkable

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How Smarteeva Solved It

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

1. Automated product registration from categorization through submission management
2. Dynamic dashboards and automated reports for global visibility of product portfolio
3. Reduced data duplicates and discrepancies through system-level validation
4. Faster response mechanism for health authorities with built-in tracking features
5. Submission type management (510(k), pre-market, etc.) with document creation and review
6. ERP integration for automated product categorization and registration steps