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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
  • Reduction of time and cost for product development and production
  • Personal medical devices
Safety and Efficacy Verification Through ICT and Big Data
  • Analysis and utilization of data extracted through medical devices
AI Based Medical Devices
  • Selection of the best medical treatment based on AI

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