Medical Device ERP Software — Built for Precision, Compliance, and Control

Real-time visibility. Full traceability. Modern manufacturing control.

In the medical device industry, precision and accountability shape every part of the manufacturing process — from design to delivery. Every step matters.

Acumatica Cloud ERP gives medical device manufacturers the visibility, traceability, and control they need to meet strict standards with confidence.

Smaller companies face the same pressures as the largest players — tight regulations, complex documentation, and zero tolerance for error. Acumatica helps you manage it all without adding extra complexity.

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A Better Way to Run Medical Device Manufacturing

From orthopedic components to diagnostic equipment and precision instruments, medical device manufacturing demands rigorous traceability, documented processes, and flawless quality control. Acumatica connects every part of your operation — from design through delivery — so nothing slips through the cracks.

Who This Is For

  • Instrument and medical device manufacturers

  • Precision component producers and contract manufacturers

  • Ophthalmology and laboratory equipment makers

  • Orthopedic, diagnostic, and monitoring device manufacturers

  • Wearable and connected medical technology companies

Even smaller manufacturers face the same regulatory pressure as the largest players. Acumatica gives you the structure to meet those demands without slowing innovation.

Key Challenges Medical Device Companies Face

Medical device manufacturing leaves no room for mistakes. Every part, process, and document must meet strict standards, and staying compliant can slow even the best teams down. Smaller manufacturers face big-company regulations with limited resources.

Acumatica Cloud ERP helps simplify it all with real-time visibility, connected workflows, and built-in traceability so you can stay compliant and move faster

Traceability Without Gaps

“Where did this part come from — and where is it now?” Acumatica provides lot and serial traceability across the entire product lifecycle, from raw materials to final shipment, making that question easy to answer.

Compliance That Doesn’t Slow You Down

With support for FDA and ISO 13485 requirements, Acumatica standardizes documentation, inspection steps, and CAPA workflows — so your team spends less time chasing paperwork and more time building.

Smarter Scheduling & Planning

Acumatica’s MRP and APS tools help stabilize production, manage capacity, and stay ahead of demand. You can plan confidently, react quickly, and keep jobs moving.

Consistent Quality at Scale

Quality control is built into the process — not tacked on. Integrated testing, inspection, and documentation keep every device within spec.

Fewer Manual Workarounds

EDI and commerce integrations remove redundant data entry. Orders, purchase commitments, and supplier communications flow directly into your system.

What Acumatica Cloud ERP Brings to Medical Device Manufacturers

Finance + Production + Engineering + Quality + Compliance + Traceability — all in one connected ERP.

Acumatica gives medical device manufacturers the visibility, control, and flexibility they need to meet strict standards without compromising operational agility.

Engineering & Production Control

  • Engineering Change Control (ECR/ECO) with approval workflows

  • Connected PLM to manage revisions, approved vendors, and documentation

  • Product configurator for complex assemblies and variations

  • Outside processing support and WIP tracking

  • Automated backflushing for material and labor

Quality & Compliance

  • Built-in inspection and CAPA management

  • Support for FDA and ISO 13485 documentation requirements

  • Audit trail and security framework

  • Warranty and service tracking for regulated products

Inventory & Traceability

  • Full lot and serial tracking from raw material to finished product

  • Expiration date controls and barcode data collection

  • Multi-site inventory with real-time WIP visibility

Planning & Scheduling

  • MRP and APS with capable-to-promise logic

  • Forecasting tools to stay ahead of demand

  • Job costing and WIP reporting

  • Automated PO creation and vendor bidding

Connectivity & Integration

  • EDI transactions with customers and suppliers

  • Integrated CRM to support service and sales

  • Flexible workflows for MTO, CTO, and ETO manufacturing

  • Open APIs for easy integration with specialized systems

Why Forward-Thinking Manufacturers Choose Acumatica

Medical device companies need more than just a system that runs production. They need a platform that can adapt as regulations shift, technologies evolve, and their business grows. That’s where Acumatica stands out.

  • Future-proof cloud platform: Open architecture and modern APIs make it easy to connect with PLM, LIMS, IoT devices, regulatory reporting tools, and other specialized systems without creating IT bottlenecks.

  • Automation and AI-driven workflows: Business events, machine-learning assistance, and real-time dashboards help your team eliminate repetitive steps, surface insights faster, and make confident decisions.

  • Built to scale: Whether you’re managing a single site or expanding globally, the platform grows with you — without forcing major rework.

This isn’t just ERP for today’s needs. It’s the foundation for a smarter, more connected future in medical device manufacturing.

Core Medical Device ERP Features

Acumatica Medical Device ERP is designed to keep your operation connected and compliant from engineering through production, quality control, and distribution. Every feature works together to give you better visibility, stronger controls, and more confidence in meeting regulatory requirements.

Traceability and Compliance

  • End-to-end lot and serial tracking from receipt to shipment

  • Expiration date control and shelf-life visibility

  • FDA and ISO 13485 support to standardize documentation

  • Full audit trail for compliance and accountability

Engineering and Product Lifecycle Control

  • ECR/ECO workflows with structured approvals

  • PLM integration to keep parts and revisions in sync

  • Product configurator for complex assemblies

  • Outside processing and cost tracking

Quality Management

  • Embedded inspections and testing

  • CAPA reporting and resolution

  • Certificate of conformance tracking and documentation

  • Warranty and service traceability

Inventory and Production Control

  • Barcode scanning for fast, accurate transactions

  • Multi-site inventory and WIP visibility

  • Job costing and automated backflushing

  • Real-time production monitoring

Advanced Planning and Scheduling (APS/MRP)

  • Forecasting and demand planning

  • Finite capacity scheduling with capable-to-promise logic

  • Bottleneck visibility and load balancing

  • Automated purchasing with vendor bidding

Connectivity, Automation & AI

  • Open cloud platform for modern integration

  • Automated workflows using business events

  • AI and ML tools that surface insights and reduce errors

  • Role-based dashboards for real-time visibility

Discover How a Modern ERP Can Streamline Processes and Transform Medical Device Manufacturing

Acumatica brings engineering, production, quality, and compliance together in one connected platform. No more hopping between systems or piecing together information — everything your team needs lives in one place.

This isn’t about adding more tools — it’s about removing roadblocks. Acumatica gives growing medical device companies a modern foundation to work smarter, adapt quickly, and stay focused on what matters most: delivering reliable products.