Master FDA compliance and speed up market-readiness. Learn how specialized ERP software helps MedTech companies navigate clinical trials and PMA with total traceability.
Expandable ERP
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Medical Device ERP Software
- FDA and ISO 13485-ready medical device ERP with full traceability
- Built-in lot and serial number tracking across BOM levels
- RMA, CAPA, and document control
- Manage work orders, kitting, quality, and vendor compliance
- Affordable, scalable medical device ERP designed for high-growth MedTech
Built for MedTech Ops
Medical Device ERP Built for the Complexity of Medical Device Manufacturing
Medical device manufacturing often means managing mixed production methods — from discrete builds of implantable devices to kitted surgical systems and serialized diagnostic assemblies. Expandable medical device ERP supports a blended manufacturing environment, so you can:
- Build to stock, build to order, or configure to order — all within one system
- Track multi-level BOMs with serialized and lot-controlled components
- Manage kitting, subassemblies, and rework with full traceability
- Comply with FDA, ISO 13485, and customer-specific quality standards
- Maintain speed and precision without compromising compliance
Whether you manufacture custom Class II devices or high-volume diagnostic kits, Expandable ERP scales with your complexity — and your customer base.
Connected Operations
One Integrated medical device ERP System.
Expandable Medical Device ERP unifies the tools you need to run a high-performing, audit-ready medical device operation. From engineering to final shipment, every function connects in one system — giving you real-time visibility, total traceability, and fewer costly surprises.
What’s built in:
- Product Lifecycle Management (PLM): Control revisions and documentation from prototype to production
- Quality & Compliance: CAPA, RMA, and audit logs — ready for FDA and ISO 13485 inspections
- Production Control: Manage work orders, multi-level BOMs, and shop floor scheduling
- Inventory & Lot Control: Track serialized parts and expiration-dated components
- Customer & Vendor Management: Oversee supplier quality, RMAs, and customer-specific builds
- Finance & Costing: Accurate job costing, margin tracking, and billing in one place
Scale Your Business from Prototype to Production
Scaling from prototype to production in MedTech? Our free whitepaper shows you how to navigate FDA compliance, implement quality systems, and leverage ERP technology for sustainable growth.
High-tech Industry Benchmarks
Don’t just get vague insights, click to learn the 10 key industry benchmarks for your growing high-tech manufacturing business.
Built to Scale Safely
Deliver More — Without Compromising Compliance
Expandable ERP gives you the traceability, control, and process visibility you need to keep products — and partnerships — moving forward.
Total Traceability
From lot-controlled components to serialized final assemblies, Expandable ensures full audit trails for every unit you produce — helping you meet FDA and ISO 13485 standards with confidence.
Built-In Quality & Compliance
RMA, CAPA, document control, and audit logs are core to our system — not bolt-ons. You get consistent, compliant workflows from day one.
Operational Precision
Manage BOMs, work orders, engineering changes, and delivery timelines in one integrated system. Keep your shop floor aligned and your customers on schedule.
ERP Quality Management: How It Drives Profit Beyond Compliance in Manufacturing
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Future-Proofing Your Medical Device Manufacturing: Emerging Trends and Innovations in ERP Systems
Upgrade your medical device ERP to drive growth. Learn how modern systems offer 89% better data accuracy, 47% faster development, and seamless compliance.
Medical Device ERP System: Essential Strategies for Lot Tracking and Recall Management
Discover how medical device ERP systems with integrated lot traceability streamline recall management and ensure FDA compliance. Expert insights for manufacturers.