Master FDA compliance and speed up market-readiness. Learn how specialized ERP software helps MedTech companies navigate clinical trials and PMA with total traceability.
ERP FOR MED-TECH STARTUPS
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A smarter path from design to production control
For startups building regulated devices, Expandable ERP provides the operational backbone for manufacturing, inventory, and traceability — and Arena PLM helps ensure product data and change control are handled the right way from the start.
Customers Who Trust Expandable
Who Is Expandable for?
1. Pre-revenue, early-revenue, and beyond
2. FDA-regulated devices or complex electronics assemblies
3. Pilot production, or scale-stage companies
What breaks between prototype and scale
Most early-stage med-tech and hardware teams can manage prototypes with disconnected tools for only so long. The real trouble starts when regulatory pressure, engineering changes, supplier complexity, and traceability expectations all hit at once.
A clearer path from product record to production reality
Arena PLM helps your team manage product data, changes, and design collaboration. Expandable ERP turns that approved product record into purchasing, inventory, production, traceability, and operational execution built for regulated growth.
- Design control: Manage product records, revisions, and approvals in Arena.
- Approved handoff: Move released product data into Expandable for execution.
- Operational control: Drive purchasing, inventory, manufacturing, and traceability in Expandable.
- Growth readiness: Support scale without rebuilding your systems later.
What breaks between prototype and production
Most early-stage med-tech and complex electronics teams can manage prototypes with disconnected tools for only so long. The real problems start when engineering changes, supplier coordination, inventory planning, and traceability expectations all collide — and teams realize the “wall” between PLM and ERP is creating delays, rework, and risk.
Expandable helps remove that wall by giving startups a practical operational backbone for what gets built, bought, tracked, and shipped.
Why startups choose Expandable
- Faster prototype-to-production handoff: Approved product data moves into operational workflows faster, reducing manual setup and delays.
- Built-in manufacturing control: Manage multi-level BOMs, purchasing, inventory, routings, and production in one system designed for complex products.
- Traceability for regulated growth: Support serial/lot tracking, audit trails, and RMAs as expectations rise from customers, regulators, and partners.
- A better long-term fit for small teams: Get the control serious manufacturers need without jumping straight into a bloated enterprise stack.
Built to Scale Safely
Deliver More — Without Compromise
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.
Not ready for a demo? Check out our resources to supercharge your production.
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.