We are at the forefront of the global medical technology industry
We have an enviable track record of design, development and delivery of innovative and successful in vitro diagnostics and medical devices spanning wearables, monitoring, implantables and IVD Point of care.
We have extensive experience in the development of Class II and Class III medical devices – from helping our clients demonstrate proof of principle design, to the inherent challenges faced in proving core technologies, creating functional prototypes, and finding manufacturing partners. Underpinning the development effort we help steer the myriad regulatory pathways which preclude market release, helping our clients transition from the benchtop through animal, first-in-human and clinical trials, and ultimately out into the market.
From sophisticated cardiac support devices involving heartbeat assistive technologies, to implantable aortic devices, to wearable neurostimulation products and cutting edge diagnostic portable x-ray machines, Hydrix has done it.
We have a dedicated and fully ISO 13485 certified Class II & III medical device development group with deep portfolio experience and the know how to deliver high end, high risk projects. Our dedicated regulatory group understands the need for a regulatory strategy, and so throughout the research and development lifecycle, plan and implement a regulatory approach to support the submission process. Working with our Clients we develop the necessary documentation to support all De Novo, IDE, PMA, 510(k) or other new product introductions.
To help support the cost of medical device development for our clients, we also work closely with the Australian government to secure market leading R&D tax credits. For our local and international clients this can translate into substantial government funded rebates to offset the cost of R&D undertaken by Hydrix.