Ingeneus specializes in the manufacture of low volume, high value medical technology. From sub-assemblies to complete products, we offer total flexibility.

Medical Device Manufacturing

Ingeneus is an ISO 13485:2016 quality accredited and FDA QSR compliant manufacturer. Our manufacturing services include:

• Contract manufacturing for existing or new products
• Ingeneus' "Manufacture by Agreement" service whereby we become the legal manufacturer, for regulatory purposes, of our clients’ products.

The Ingeneus manufacturing team considers the following in any project:

• Product transfer. Any efficient manufacturing project starts with a successful transition. Ingeneus is able to quickly transition both new products and mature products into our Melbourne facility.
• Supply chain management. Ingeneus has invested considerable time qualifying suppliers, both local and international, in accordance with our ISO 13485:2016 system for all types of services and component supply.
• Production. Ingeneus understands that it is critical to the quality and performance of any device to execute a repeatable and consistent production process.
• Service and post market surveillance. Our ability to provide ISO 13485:2016 accredited service and post market support sets Ingeneus apart from other service providers.
• Logistics. We take care of the medical technology industry's strict traceability requirements, saving time and money for clients.