Medical Device
Industry
Understanding of the Industry
| The Features of Medical Device Industry |
|---|
It is an industry related to people’s life and health (high level of safety and efficacy verification) |
High level of growth and safety (Less effect from regulation system or business cycle) |
Periodic sales are important (Maintenance, supply of supplies, and additional service) |
Traceability management through Lot No. and serial No. is necessary (UDI, Medical device supply report) |
| The Future Paradigm of Pharmaceutical Industry |
|---|
Ultra-precision Medical Device Industry Utilizing 3D Printing
|
Safety and Efficacy Verification Through ICT and Big Data
|
AI Based Medical Devices
|
Medical Device Industry Issues & Solutions
Product Lot (serial) tracking
- It supports Lot tracking of entire process from production result → raw material input → purchase GR based on the purchase Lot No
UDI & Medical Device Supply Report
- Implementation of K-System Ace medical device ver. → Link with medical device supply detail solution based on the ERP GI
- Support for sending serial number and supply history through linking ERP and medical device supply history report management system
WMS/MES link and UDI & Medical Device Supply History Report Integrated Data Management
- Production work order (ERP) → Production result management (MES) → Production result/input result (ERP)
- Purchase supply, GR/GI, moving (ERP) → Shipping, return processing (WMS) → Delivery note (ERP)
CS Management
- After delivery of medical equipment, a/s, consumable sales management, maintenance management, replacement equipment processing
