Leading Medical Device Company

Drag. Drop. Done: Faster Complaint Intake with Smart Duplicate Handling

New complaint import time dropped from 40 minutes to under 1 minute, and duplicates dropped by up to 95%.
Quality Operations Lead
Leading Medical Device Company
95%
Duplicate reduction within 6 months of go-live
<1 min
Bulk import time (down from 30-45 minutes)
15 days
Median complaint cycle time (down from 45-60 days)

A leading medical device company known for minimally invasive, durable solutions that improve women's quality of life needed a complaint-handling system that could keep pace with real-world speed without sacrificing control, documentation, or governance. Smarteeva partnered with them to bring complaint intake, IMDRF coding, investigations, and MDR readiness into one guided CRM workflow, now enhanced with Agentic AI.

New complaint import time dropped from 40 minutes to under 1 minute, and duplicates dropped by up to 95%.

The Challenge

High-volume complaint intake with duplicate risk and disconnected investigations

  • Multiple intake channels created inconsistency and rework across teams and regions
  • High-volume intake increased the chance of duplicate complaints
  • Reportability decisions needed consistency and a guided, defensible process
  • Investigations, MDRs, and complaint records were not connected in the workflow
  • Changes after closure needed to be restricted and fully traceable for audits

How Smarteeva Solved It

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

  1. End-to-end complaints application in Salesforce with guided workflow from intake to closure
  2. Three intake methods (email-to-complaints, manual entry, bulk import) all landing in the same structured workflow
  3. Duplicate-smart importing with preview-step validation, checking both within file and against existing Salesforce records
  4. IMDRF code management synced directly with MDRs (add on complaint = appears on MDR)
  5. Guided MDR decision tree with automatic investigation and MDR record creation
  6. Role-based approval, closure governance, and controlled reopening with full audit trail

Results

95%
Duplicate reduction within 6 months of go-live
<1 min
Bulk import time (down from 30-45 minutes)
15 days
Median complaint cycle time (down from 45-60 days)
<0.001%
IMDRF/MDR code mismatch rate (down from 9%)