Batch/serial traceability coverage
Fully traceable shipments ÷ total shipments
↑ 100%
Solutions · Industries · Medical Devices
SAP Business One for Medical Devices:
Quality Records, Traceability and System Integration
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 Gold Partner MTC · Delivering since 2009 · 760 clients served
Compliance traceability, quality records and system integration
Strict regulatory traceability requirements
ISO 13485, CE (MDR), FDA 510(k) and GSP require controlled batch, serial-number and process records that are difficult to maintain consistently on paper and in Excel.Management impact: Audit and regulatory-inspection preparation takes longer and carries compliance risk.
Disconnected R&D and production data
Design changes are recorded separately in PLM, MES and ERP without a controlled mechanism for transferring approved changes to production.Management impact: This can cause version differences, rework and material loss.
Manual license and expiry management
Product registrations, manufacturing licenses and sterilization expiry dates are maintained in manual registers.Management impact: Late identification of approaching expiry dates can affect production or shipment.
Incomplete links among distribution and service records
With dealer and direct-sales channels in parallel, device location, installation and maintenance records are not consistently linked by equipment.Management impact: Recall tracing, equipment service and maintenance-record retrieval are affected.
Business Process and Controls
Design change, production inspection, distribution and service traceability
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
Stock +↓ Batch + serial + UDI run through the whole chain
Distribution & Service
Delivery
Stock −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 in medical-device operationsDesign-change approval flowBatch, serial-number and UDI traceability across operationsInspection and release controlLicense and expiry alerts
Involved: R&D, regulatory, production, quality, warehouse, sales, service, finance · Modules used:ProductionInventory (batch/serial)Purchasing–A/PSales–A/RService
Project Measures
Medical-device project outcomes and acceptance measures
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%
| Core Metric | Formula | Target |
|---|---|---|
| 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% |
Project Outcomes & Acceptance Measures
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
Implementation Priorities for Medical Devices
Compliance Traceability, R&D and Production Coordination, and Service Management
Implementation priorities include batch, serial-number and quality records, coordination between design changes, production and supply, and management of equipment, distribution traceability and after-sales service.
1
Batch, serial-number and quality records
Implementation scope: Record batch, serial and UDI data across receipt, production and shipment; retain inspection results and release approvals for traceability and audit review.
SAP Business One and extensions:
B1 batch/serial managementUDI labelingInspection & release flowLicense expiry alerts
Acceptance focus: receipt-to-shipment trace records available · inspection and release records complete · audit evidence exportable
2
R&D, production and supply-chain coordination
Implementation scope: Integrate PLM, MES and WMS, link approved design changes to production BOMs, and post operational transactions to the corresponding financial records.
SAP Business One and extensions:
Design-change linkagePLM/MES interfacesWMS/tax integrationIntegrated finance
Acceptance focus: changes land in ≤2 days · one ledger across systems · operations and finance in sync
3
Distribution, equipment and service management
Implementation scope: Equipment cards + installation & maintenance history + proactive expiry reminders + AI spare-parts and quality analytics: service shifts from reactive response to a predictable value stream.
SAP Business One and extensions:
Equipment cards & maintenanceService contract managementAI spare-parts forecastingAI quality analytics
Further improvement: recall tracing in hours · higher maintenance renewals · quality data feeding back to R&D
SAP Business One Core1+N SuiteAI Applications
Related Cases
Medical-device implementation outcomes
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.
View case
An orthopedic device companyIntegrated PLM and MES with ERP across R&D, production, sales and maintenance to support quality and cost traceability.
View case
An IVD / medical companyGSP-compliant partner and process traceability; ten subsidiaries unified under HQ management and reporting.
View case
FAQ
Implementation and system requirements for medical devices
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.
Assess device traceability, quality records and service requirements
Talk to our medical-device industry consultants — starting with compliance traceability and system integration, see how B1 supports your quality system.
- ✓Batch, serial-number and UDI traceability across operations
- ✓PLM, MES and WMS integration
- ✓GSP and ISO 13485-related process configuration