Engineering certified software for medical, defence, and mission-critical systems requiring reliability, traceability, and compliance.
Hydrix develops embedded software for systems where failure is not an option. From implantable pumps and neuromodulation devices to diagnostic platforms and defence subsystems, our engineers deliver software that meets stringent global standards and operates with uncompromising reliability.
We specialise in the design and verification of safety-critical software, applying deep knowledge of embedded systems, system safety, and regulatory pathways. Our software lifecycle approach integrates early and continuous risk management as an integral part of the design process, continuous traceability, and rigorous verification to ensure compliance with standards such as IEC 62304, ISO 14971, and FDA CFR 820.
Integrated Development Approach
Our software team works closely with systems, electronics, human factors, and QA functions to ensure alignment across architecture, implementation, and verification. We participate in Hazards Analysis, Risk Analysis (including FMEAs) , and design reviews from early-stage development to ensure software risks are well-understood and controlled.
We have delivered software that supports:
- Life-sustaining cardiovascular platforms
- Wearable and implantable devices
- Clinical diagnostic and imaging systems
- Field-ready industrial and defence hardware
We support client teams across all development stages, including:
- Initial architecture and documentation
- Prototyping and MVP software for usability and early clinical feedback
- Class III product software ready for FDA submission and audit
Why Hydrix
What sets us apart is the depth of our people and the integration of skills across disciplines. Hydrix brings safety, regulatory, and software engineering expertise together under one roof to develop robust, high-performance systems. Our team understands the demands of regulated markets and mission-critical environments, and we build software that meets the highest global safety and compliance standards.