Leading Glucose Monitoring Manufacturer
Smarteeva Solves High-Volume Complaint Handling for a Leading Glucose Monitoring Company
Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.
VP of Quality Operations
Leading Glucose Monitoring Manufacturer
5M+
Annual complaints processed without performance loss
300K+
MDRs handled annually on the platform
Minutes
MDR creation to FDA submission time
About
Dexcom
One of the largest manufacturers and producers of glucose monitoring systems required an overarching system for Post-Market surveillance and effective complaint management. Despite having a quality system, the ever-changing business landscape and growing volumes made scalability impossible without a new approach.
Industry
Diabetes Technology / Glucose Monitoring
Painpoint
3M annual complaints overwhelming existing QMS, 25-step complaint lifecycle, untouchable customizations
Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.
The Challenge
5M annual complaints overwhelming existing QMS, 25-step complaint lifecycle, untouchable customizations
- Previous QMS not scalable: 5M+ annual complaints and 300K+ MDRs needed speed and responsiveness
- Extensive customizations made the previous system untouchable; any update caused outages
- 25 process steps required to go through the complaint lifecycle
- User community could not track information changes or make informed regulatory decisions
How Smarteeva Solved It
Smarteeva partnered with the customer to design and deploy a purpose-built solution:
- Scalable platform with no performance loss at 5M complaints and 165M+ Audit Trail entries
- User-friendly Audit Trail UI to help users quickly identify critical information
- Fully automated MDR reporting: creation, completion, and FDA submission in minutes
- Automated decision trees and regulatory reports for EU and multiple countries
- Scalable integration with customer service applications exchanging 250K+ daily messages
Results
5M+
Annual complaints processed without performance loss
300K+
MDRs handled annually on the platform
Minutes
MDR creation to FDA submission time
250K+
Daily messages exchanged via service integration
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