Solutions · Industries · Medical Devices
Compliant traceability from R&D to service
SAP Business One for Medical Devices
SAP Business One builds on native batch and serial-number management — with UDI labeling, inspection records and equipment cards — to meet the full-traceability demands of ISO 13485, GSP and similar regulations.
Batch/serial traceability↑
100%
Inbound to shipment, end to end
Trace response time↓
Days→hours
Recall scope pinned down fast
System silos↓
One ledger
PLM/MES/WMS share one source with ERP
SAP Business One（B1）金牌伙伴MTC · 17年实施经验 · 已服务350+ 家成长型企业
For device makers, the pain concentrates in compliance traceability and data gaps
Strict regulatory traceability
ISO 13485, CE (MDR), FDA 510(k) and GSP demand rigorous batch/serial and process records — paper and Excel can't keep up→ 代价：Long audit prep, compliance risk hanging over you
R&D–production data gap
Design changes are frequent, but PLM, MES and ERP each own a fragment, so changes don't reach the shop floor→ 代价：Rework, wasted material, version mismatch
Scattered license & expiry tracking
Product registrations, manufacturing licenses and sterilization expiry live in manual spreadsheets→ 代价：Expiries surface late and block shipments
Broken chain after shipment
With dealers and direct sales in parallel, device whereabouts, installation and maintenance records don't connect→ 代价：Slow recall tracing, reactive service
核心可信度模块 · 端到端业务流
One traceable flow from R&D through production to the field
SAP B1 links design changes, production QC and field service into a single traceable chain through batch/serial management, inspection & release, and equipment cards.
R&D & Registration
Engineering BOM
Design Change
License Records
↓ Approved changes sync to the production BOM
Production & QC
Prod. Order (Batch/SN)
In-Process QC
Release + Receipt
库存 +↓ Batch + serial + UDI run through the whole chain
Distribution & Service
Delivery
库存 −Install + Equipment Card
Service & Recall Trace
B1 natively enforces batch and serial-number capture at every goods movement — trace backward to raw-material batches, forward to where each unit shipped. MTC configures inspection, release and traceability flows to GSP / ISO 13485 requirements; approved design changes sync to the production BOM automatically, and equipment cards keep installation and maintenance history so a recall can be scoped by batch within hours.
Key control points (where the device chain breaks most often)Design-change approval flowBatch/serial/UDI end-to-end traceInspection & release controlLicense & expiry alerts
Involved: R&D, regulatory, production, quality, warehouse, sales, service, finance · Modules used:ProductionInventory (batch/serial)Purchasing–A/PSales–A/RService
核心可信度模块 · 指标 × 公式 × 目标方向
Once the device chain is under control, watch these metrics
| 核心指标 | 计算公式 | 目标方向 |
|---|---|---|
| Batch/serial traceability coverage | Fully traceable shipments ÷ total shipments | ↑ 100% |
| Trace response time | Trace initiated → batch whereabouts located | ↓ ≤2 hours |
| Design-change cycle | Change approved → production BOM updated | ↓ ≤2 days |
| License/expiry alert coverage | Auto-alerted items ÷ items requiring control | ↑ 100% |
Before → after (typical results)
100%industry benchmark
Full batch + serial traceability; recall scoping cut from days of digging to hours
6 systems
One platform integrating MES, OA, WMS, PLM, CRM and Golden Tax — silos merged into one ledger
10 entities
In a post-acquisition integration, ten subsidiaries run under unified HQ management and reporting
Days→hoursindustry benchmark
Quality and trace records kept digitally; audit material pulled on demand instead of assembled for days
Figures above are typical results from MTC-implemented B1 customers and industry benchmarks (anonymized); actual outcomes depend on company size and process complexity. Items tagged "industry benchmark" are not single-customer measurements.
Our stance for this industry · The medical-device digital ladder
From compliant traceability to R&D–production sync and service value
For device makers, digitalization starts with getting batches, serial numbers and inspection records into the system — a regulatory requirement and a management foundation in one. With that layer solid, design changes and cross-system data can stay in sync; once equipment cards and service data plug in, every unit in the field keeps creating value.
↑ The higher you go, the more R&D, production, sales and service align
1
Traceability & quality foundation (Compliance)
在做：Batch/serial/UDI captured end to end, inspection records digitized, release approvals live — every unit accounted for from inbound to shipment, audit material available on demand.
靠B1哪层：
B1 batch/serial managementUDI labelingInspection & release flowLicense expiry alerts
Result: end-to-end trace · inspection on record · audits without scramble
2
R&D–production–supply sync (Integration)
在做：PLM/MES/WMS integrated, design changes linked to the production BOM, operations flowing straight into finance — each system does its job, one ledger tells the story.
靠B1哪层：
Design-change linkagePLM/MES interfacesWMS/tax integrationIntegrated finance
Result: changes land in ≤2 days · one ledger across systems · operations and finance in sync
3
Field service as a value line (Intelligence)
在做：Equipment cards + installation & maintenance history + proactive expiry reminders + AI spare-parts and quality analytics: service shifts from reactive response to a predictable value stream.
靠B1哪层：
Equipment cards & maintenanceService contract managementAI spare-parts forecastingAI quality analytics
Direction: recall tracing in hours · higher maintenance renewals · quality data feeding back to R&D
B1内核1+N套件AI应用
相关案例
What changed for device makers once traceability and data were under control
Selected cases on compliance traceability, multi-system integration and group consolidation. Client names and detailed figures live on the case pages.
A Jiangsu-based medical device company
Integrated MES, OA, WMS, PLM, CRM and Golden Tax; own-brand and OEM flows unified from R&D through the supply chain.
查看案例
An orthopedic device companyIntegrated PLM and MES with ERP across R&D, production, sales and maintenance to support quality and cost traceability.
查看案例
An IVD / medical companyGSP-compliant partner and process traceability; ten subsidiaries unified under HQ management and reporting.
查看案例
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常见问题
Questions quality and IT leads in medical devices ask most
How far can B1 take UDI and batch traceability?
B1 natively supports batch and serial-number management with mandatory capture at goods movements. MTC configures UDI labeling and printing to your rules — trace backward to raw-material batches, forward to shipment destinations, and scope a recall fast.
We already run MES, PLM and WMS. Do we have to replace them?
No. B1 serves as the operations-and-finance backbone while MTC connects MES, OA, WMS, PLM, CRM and tax systems through interfaces (we have delivered projects integrating six system types at once). Each system keeps its job; the data lives in one ledger.
How does the system help during an ISO 13485 or GSP audit?
Inspection records, release approvals and batch movements are all kept in the system. The traceability chain an auditor asks for can be exported by batch — audit prep turns from days of assembling files into pulling records on demand.
Make every device stand up to a trace
Talk to our medical-device industry consultants — starting with compliance traceability and system integration, see how B1 supports your quality system.
- ✓Batch/serial/UDI end-to-end traceability
- ✓Hands-on PLM/MES/WMS integration experience
- ✓GSP / ISO 13485-aligned process configuration