Medical Device Manufacturing ERP: ISO 13485, Unique Device Identification & DHR Management
Streamline medical device compliance from prototype design transfer to commercial release. Protect patient safety with verifiable Device History Records.
Source Integrity Rule: EU MDR EUDAMED database direct upload API integration requires custom endpoint authorization [PRODUCT CAPABILITY TO CONFIRM].
Mandatory Regulatory & Quality Standards
Operational Bottlenecks in Medical Devices & Diagnostics
Challenge 01
Paper-based Device History Records taking days to audit and approve before product release
Challenge 02
FDA warning letters resulting from uncontrolled changes to Device Master Records
Challenge 03
Difficult sterilization lot reconciliations causing inventory release bottlenecks
End-to-End Shop Floor Execution Workflow
DMR Revision Lock
Manufacturing bills of materials, routings, and inspection limits locked to approved DMR baselines.
Cleanroom Assembly Tracking
Technicians log lot-controlled components with cleanroom particle counts and operator sanitization logs.
Sterilization Batch Validation
Sub-assemblies grouped into sterilization runs; biological indicator results confirmed before release.
UDI Barcoding & DHR Closeout
Laser etch or thermal label unique device identifier (DI + PI) and compile complete digital DHR.
Core Functional Modules for Medical Devices & Diagnostics
Key Industry Performance Indicators (KPIs)
Target KPI 01
DHR Approval Turnaround Time
Target KPI 02
Sterilization Lot Yield %
Target KPI 03
Non-Conformance Rate
Target KPI 04
UDI Verification Accuracy
Frequently Asked Architecture & Compliance Questions
Does Werkora generate GS1 compliant UDI barcodes?
Yes. Werkora formats GS1-128 and Data Matrix barcodes with mandatory Device Identifier (DI) and Production Identifiers (PI: lot, serial, expiry) [PRODUCT CAPABILITY TO CONFIRM].