Hydrix

Full-Lifecycle MedTech Product Design, Engineering, and Regulatory Advisory

Hydrix (ASX: HYD) is an ISO 13485-certified product design, engineering consultancy, and medtech commercialization group headquartered in Australia. Founded in 2002, the firm specializes in end-to-end development for Class II and Class III medical devices, surgical systems, point-of-care diagnostics, and digital health platforms. Hydrix operates through specialized service units covering engineering, ventures, and technology distribution (such as cardiovascular and remote patient monitoring platforms).

Core Engineering & Advisory Capabilities

• Complex Systems & Biomedical Engineering: Designing high-reliability software, safety-critical electronics, mechanical systems, and embedded firmware for implantables, surgical robotics, and imaging systems.
• Human-Centered Design & Usability: Integrating industrial design, user interface (UI/UX) architecture, and human factors engineering (IEC 62366) to build compliant, clinician-friendly devices.
• AI, IoT & Secure Cloud Architecture: Developing connected medical software, cloud analytics, and edge-computing solutions with built-in cybersecurity frameworks (IEC 62304).
• Regulatory & Quality Systems (QMS): Navigating global regulatory strategy, FDA/CE compliance, ISO 14971 risk management, and clinical translation pathways to support clients from early concept to commercial rollout.