ERP Built for Medical Device Manufacturers
From component procurement to finished device, manage production, quality, traceability, and regulatory compliance with one purpose-built system.
Why Generic ERPs Fail Medical Device Manufacturers
No Device History Records
Regulatory bodies require complete Device History Records (DHR) for every device manufactured. If you are building these manually or stitching data from multiple systems, you are one audit away from a compliance failure.
Component Traceability Gaps
Medical devices have hundreds of components from dozens of suppliers. If a component is recalled, can you identify every finished device that used it within minutes? Most manufacturers cannot.
Quality is Fragmented
Incoming inspection, in-process checks, and final testing happen in different systems or on paper. Connecting a customer complaint back to a specific batch, component lot, and supplier is a manual investigation that takes days.
Built for MedTech
Complete Traceability. From Component to Patient.
BNBRun ERP gives medical device manufacturers the production control and traceability that regulators demand, without the complexity and cost of enterprise systems designed for multinational corporations.
✔ Device History Records (DHR) generated automatically from production data
✔ Component-level traceability with forward and reverse lot tracking
✔ Integrated quality system — incoming, in-process, and final inspection in one workflow
✔ UDI (Unique Device Identification) support for regulatory compliance
✔ Production planning with BOM management for multi-component assemblies
✔ Complaint handling linked to batch, component, and supplier data
Key Modules for Medical Device Manufacturing
Every module is designed for how medical device manufacturers actually work
Production Planning
Plan production with multi-level BOMs for assembled devices. Schedule work orders, track component availability, and manage sub-assembly production. Visual production status tracking.
Quality Management
Three-stage quality system: incoming material inspection, in-process checks at each production step, and final device testing. All results linked to the device serial/lot number.
Device Traceability
Forward traceability: which devices used this component lot. Reverse traceability: which component lots went into this device. Complete genealogy for every finished device.
Inventory & Lot Control
Track components, sub-assemblies, and finished devices by lot/serial number. Manage shelf life, storage conditions, and quarantine zones. Auto-block expired or rejected lots.
Procurement
Approved Supplier List (ASL) management. Supplier audit tracking. Purchase orders linked to production demand. Incoming material goes to quarantine until inspection is complete.
Regulatory & DHR
Auto-generate Device History Records from production data. Maintain Design History Files. Track CAPA, deviations, and non-conformances. Audit trail on every record.
Compliance Built Into Every Workflow
Medical device manufacturing is one of the most regulated industries. BNBRun ERP builds compliance into every workflow so your team does not need to think about it separately.
CDSCO Medical Device Rules 2017
Production and quality workflows aligned with regulatory requirements
ISO 13485
Quality management system support with documentation, traceability, and process controls
FDA 21 CFR 820
Quality System Regulation support for design controls, production, and corrective actions
UDI Compliance
Unique Device Identification tracking and labeling support
Device History Records
Automatically compiled from production, QC, and material data
CAPA Management
Log, investigate, and resolve corrective/preventive actions with root cause tracking
Before BNBRun vs After BNBRun
See BNBRun ERP in Action for Medical Devices
Book a free 30-minute demo configured for medical device manufacturing. We will show you traceability, DHR, and quality workflows with MedTech-relevant data.
✔ Free 30-min demo ✔ MedTech-specific data ✔ No commitment
Frequently Asked Questions
Does BNBRun support ISO 13485 compliance?
Yes. BNBRun supports the documentation, traceability, and process control requirements of ISO 13485. While the ERP itself is not a certified QMS, it provides the system infrastructure that makes maintaining ISO 13485 compliance significantly easier.
Can it handle multi-level BOM for assembled devices?
Yes. BNBRun supports multi-level BOMs with sub-assemblies. You can plan production at the component level, track sub-assembly completion, and assemble finished devices — all with lot-level traceability at every stage.
How does Device History Record generation work?
BNBRun automatically compiles DHR from production data: which materials were used (lot numbers), who performed each step, QC test results, any deviations, and final inspection results. You can generate the complete DHR with one click.
What about UDI tracking?
BNBRun supports Unique Device Identification assignment and tracking. Each device or device lot can be assigned a UDI that carries through from production to dispatch documentation.
How long does implementation take?
For medical device manufacturers, 30-45 days. We spend extra time mapping your quality processes and configuring inspection checkpoints to match your specific device requirements.
Is there a mobile app?
Yes. Available on Google Play and Apple App Store. Production supervisors can update work order status, QC teams can record inspection results, and managers can approve actions from anywhere.
