A Jiangsu-based Medical Device Company (Confidential)
Connected MES/OA/WMS/PLM/CRM and tax systems on SAP Business One for unified processes and data
- Chinese name
- 某江苏医疗器械企业
- Location
- Jiangsu, China
- Industry
- Medical device manufacturing
- Products & Services
- Medical devices (own + custom brands)
- Partner
- MTC
- Solution
- SAP Business One
Client name and identifying details withheld to protect privacy
Project Summary
Tied ISO13485 compliance into the system to meet compliance and traceability requirements
Connected MES, WMS, PLM, CRM and tax systems, eliminating departmental information silos
Company Profile
To protect the client's privacy, this case withholds the name and identifying details; only industry and solution are shared.
This is a Jiangsu-based medical-device company making blood-lancet and surgical instrument products sold worldwide. Such firms must satisfy ISO13485, CE (MDR) and FDA 510k requirements for quality and traceability across multiple jurisdictions, while siloed MES, WMS, PLM, CRM and tax systems fragment the organization. With SAP Business One at the core, MTC tied ISO13485 compliance into the system and integrated MES, OA, WMS, PLM, CRM and tax systems, unifying own-brand and custom-brand flows from R&D to supply chain across online and offline, fully connecting business to finance, and enabling mobile approvals via WeCom.
Business and Management Requirements
Management Requirements Before Implementation
- Products are sold worldwide and must meet ISO13485, CE (MDR) and FDA 510k requirements for quality and traceability across multiple jurisdictions
- MES, WMS, PLM, CRM and tax systems operated independently, creating departmental information silos
- The data channel from business to finance was not fully connected, making information, logistics and cash flows hard to keep consistent
- Approvals needed to go mobile and be handled anytime, anywhere
Implementation Goals
- Apply ISO 13485 controls in the system and maintain traceability across R&D, procurement, production, quality and delivery
- Connect departmental systems so they can exchange approved master data and transaction records
- Fully connect the data channel from business to finance so information, logistics and cash flows stay consistent
- Integrate WeCom for mobile approvals
Systems and Applications in Scope
Implementation partner: MTC
Implementation Outcomes
- Fully connected the data channel from business to finance, keeping information, logistics and cash flows consistent
- Integrated WeCom for mobile approvals, handling processes anytime, anywhere
- Meets China local tax and fiscal compliance (Golden Tax integration) and ISO 13485 traceability requirements
- Own-brand and custom-brand flows from R&D to supply chain are managed uniformly across online and offline
- Business and finance data are connected, traceable and consistent in definition
- Multi-system coordination lifted overall operational efficiency and compliance together
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