Is your system built to pass the test from prototype to production?
Recall, CAPA, surprise audit — the question changes, the source of truth doesn't. Pick a scenario and watch Expandable answer from the auditor's seat.
"We need every site that received Lot 4471-B. Today."
Expandable rebuilds the supplier → lot → serial → point of care chain in seconds. Every UDI is already mapped to a shipment and a care site.
Field notes from the regulated production floor.
If it's not documented, it didn't happen.
Your product may be great — but if you can't prove each step of your manufacturing process, your approval timeline can get messy fast.
Read the touchpointTraceability from supplier to patient.
How fast can you provide a complete trace? That's the line between a contained issue and a regulatory problem.
Read the touchpointSurgical device & kit tracking.
Dozens of components — each with its own lot, expiration, supplier, and sometimes sterilization cycle. Generic inventory systems can't keep up.
Read the touchpointDesign control is not production control.
When engineering releases an approved ECO, how quickly does production start building to the new spec? If the answer involves spreadsheets, that's a problem.
Read the touchpointBuilt by people who know FDA.
When implementation consultants have never shipped a 510(k), they learn on your timeline — and that means delays, expensive fixes, and avoidable risk.
Read the touchpointBig ERP capabilities on a small budget.
Enterprise‑level compliance doesn't require enterprise‑level spend — when the system is purpose‑built for med‑tech.
Read the touchpointDrag the chain. Watch Expandable trace it.
Pick any point — a clinic, a serial, a raw-material lot — and Expandable walks the chain in both directions in seconds. No spreadsheet archaeology.
The same record powers ECO impact, recall scoping, and supplier corrective action — without exporting to a separate quality system.
Pick your seat. See your Expandable.
Every lot, every kit, every shipment — one record.
Run the floor without juggling spreadsheets. Expandable handles BOM revisions, ECO flow, kit builds and consignment in a single, audit-ready record from the day you start shipping.
Mid-market device makers cut month-end close from days to hours.
Expandable at the core. The stack around it, open.
A modern, API-first core sits at the center — and opens out to the QMS, PLM, CRM, EDI, CAD, BI and AI tools your team already runs. No rip-and-replace, no lock-in. Hover an orbit to see how it plugs in.
Hover an orbit to see how it connects
The same ERP from your first prototype to your first million units.
Submission artefacts assemble themselves from the same record your engineers already use. Less hand-curation, fewer surprises.
From Prototype to Production: How To Scale Your MedTech Manufacturing Business
Get the whitepaperPurpose-built mid-market — not bloated enterprise, not thin small-business.
Right where you are
Purpose-built for high-tech and med-tech manufacturers with complex BOMs, FDA documentation, and growth ambitions. Configured in weeks, scales for decades.
Designed for exactly this size and stage.
Closing scene
Book the walkthrough.
45 minutes. Your BOM, your serials, your audit story — running on Expandable, live.