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 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 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 accredited service and post market support sets Ingeneus apart from other service providers.