MEDICAL DEVICE MANUFACTURING

Compliance inside production, not beside it

In medical device manufacturing the record is part of the product. A device that cannot show its history, materials and inspections is not finished, whatever the assembly line says. Systems that keep quality records beside production instead of inside it manufacture that risk daily.

Visibility ERP puts the compliance record inside the production system. Design flows in through CAD integration for design-to-order work, or through the parametric product configurator for configure-to-order devices. Comprehensive lot and serial management carries as-quoted, as-designed, as-sold and as-built configuration history on the production record, and enterprise quality management runs inspections, verifications and corrective actions inside shop floor operations. Material planning and capacity management keep validated processes running on schedule, with supply chain collaboration covering critical component suppliers.

Compliance and regulatory reporting, including FDA 21 CFR Part 11 and UDI support, reads from those same records, alongside the metrics and analytics that track cost and profit objectives.

From as-designed to as-built, provably

The device history record is only as good as the moment it was captured. Because inspections, material lots, operator actions and configuration changes are recorded at the operation as work happens, each device's history assembles itself during production. Audit preparation becomes review, not reconstruction.

Post-market, full service management, including remote monitoring, preventative maintenance and service partner integration, runs against the same device records, so the field history and the build history stay one story.

Common questions from medical device manufacturers

Does Visibility ERP support FDA 21 CFR Part 11 and UDI?

Yes. Compliance and regulatory reporting including FDA 21 CFR Part 11 and UDI runs from the production records themselves, in the same system that executes the work.

How is the device history record maintained?

It builds during production: lot and serial data, inspections, verifications and corrective actions are captured at the operations that produce them, with as-quoted, as-designed, as-sold and as-built configuration history intact.

What does an audit look like on this system?

The evidence is the production record, so an audit is navigation rather than assembly: from any device, back through its operations, materials, lots and inspections, with documents linked where they apply.

How long is a typical implementation?

Four to six months for most companies, run by our in-house team. Since 1988, none have failed, which is the kind of track record regulated manufacturers tend to ask about first.

Cloud or on premise?

Both are supported. The same browser-based system runs as SaaS managed by our team or on premise under your own controls.