Service & Support

Installed, validated and supported — worldwide

A production machine is only as good as the support behind it. Every Universal Balloon Medical system ships with on-site installation, validation support, training and spare parts, so your line reaches qualified production and stays there.

What's included with every machine

End-to-end support from delivery to steady-state production — wherever you are.

Installation & commissioning

Our engineers install, set up and commission the equipment on your production floor, hand over acceptance testing, and confirm it runs to spec before sign-off.

IQ / OQ / PQ validation support

We provide installation, operational and performance qualification support with the documentation your quality team needs for ISO 13485 and FDA-regulated production.

Operator & maintenance training

Hands-on training for operators and maintenance staff — setup, changeover, routine upkeep and troubleshooting — so your team runs the line independently.

Remote diagnostics & support

Fast remote diagnostics and technical support to resolve issues quickly and minimize downtime, with on-site service dispatched when needed.

Spare parts & consumables

Genuine spare parts, tooling and consumables kept available and shipped to your region, with recommended spares lists to keep critical stock on hand.

Preventive maintenance

Scheduled preventive maintenance and calibration to protect yield, accuracy and uptime over the full life of the equipment.

From order to qualified production

How a project runs

Specification & acceptance criteria

We align on your device, throughput and tolerance requirements and agree factory acceptance criteria before build.

Factory acceptance & shipment

The machine is tested and accepted at our facility, documented, then crated and shipped to your site.

On-site installation & IQ/OQ/PQ

Our engineers install and commission the system and support installation, operational and performance qualification with full documentation.

Training & ongoing support

We train your team, then back you with remote diagnostics, spare parts and preventive maintenance for the life of the machine.

Built for regulated production. Our equipment is designed to support ISO 13485 and FDA-regulated manufacturing, with IQ/OQ/PQ documentation and MES-ready, SQL-based process traceability on every machine.

Planning a new line or a capacity expansion?

Tell us your device, volumes and timeline. We'll map the equipment, validation and support plan for your region.