At the forefront of medical device technology
Who Are We:
Whether it is clinical trials, design and development, manufacture, logistics, accreditation, regulatory approval or post market surveillance, Ingeneus provides a complete service.
Ingeneus is quality certified to ISO 13485 and is FDA QSR compliant. We offer a complete service all the way from conception to market and offer the benefit of our extensive experience in the Australian, Asian, European and US markets.
Ingeneus is a team of world class engineers and manufacturing specialists dedicated to the field of medical technology. We work to understand the unique issues presented by each client and then work closely with them to deliver proven high quality outcomes, on budget and within deadline.
What We Do:
Our services are all quality system accredited and include:
- Development and engineering activities.
- Manufacture including product transfer, supply chain management and production.
- TGA, FDA and CE Mark regulatory approval of medical devices.
- Technical service and post market surveillance.
- Product commercialisation, distribution and marketing.
Ingeneus is ISO 13485 accredited giving you the best people, processes and value. We understand the issues of our clients, and we work closely with them to deliver proven high quality outcomes, on budget and within deadline.
At Ingeneus we offer flexible processes to get your product from idea to practice. If our clients have existing capability, they can pick and choose services from our value chain to suit their needs. This allows clients to focus on their core business, and utilise our existing systems, rather than establishing all the product capability in-house.
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Factory 3, 17 Waldheim Rd, Bayswater, VIC, 3153
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