Hydrix has an enviable track record of design, development and delivery of many successful and innovative laboratory instrumentation systems and medical devices, from Class 1 low-risk up to Class 3 high-risk (and software Class A to Class C).
The Hydrix team has developed a wide array of devices, diagnostics and instruments across life sciences including point of care and laboratory equipment for a wide range of disciplines including cardiology, neurology, pathology, haematology, gastroenterology, electromyography and many others.
With our broad application experience and technical versatility, Hydrix brings our ISO 13485 quality control system to the design and development of medical devices and instruments:
• Class I to Class III high risk devices, with recent projects including:
• In-chest mounted heart beat assist device for sufferers of advanced heart disease (Class III)
• Productisation of a Class IIa constipation treatment device
• A class II incontinence management device
• Software development of a Class I app for smartphones to assist in the treatment of tinnitus
• Atomic Absorption Spectrophotometer redesign for obsolescence
• Complete physical devices, including industrial design, human machine interface and apps, electronics, software and mechanical systems, test, QA, regulatory submission support and supply
• Creation of complete design history files to support US FDA (510(K), PMA & De Novo), European CE and Australian TGA submissions support.
• Design to a variety of obligatory international device development standards, including:
• IEC 62304 – Medical device software – software life cycle processes
• ISO 14971 – Application of risk management to medical devices
• IEC 60601 – Safety for programmable electrical medical systems
• Consultancy services for Client's medical device programs for an extensive range of medical companies, from global organisations such as Cook Medical and Agilent to emerging companies such as GI Therapies and Analytica
Design and Development Process
Hydrix uses a proprietary stage-gate process designed to address the business, program and technical risks early in the project, whilst streamlining the product development stage using lean techniques and flexible project execution.
Hydrix is a proud member of the BioMelbourne Network, the peak industry forum for the leaders of the Victorian biotechnology industry and QMED Network, the world's largest Biomedical procurement association