Medical and Scientific

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).


 

Experience

 

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.

Industry Membership


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