Developing medical devices requires a unique blend of engineering, compliance and innovation. We specialise in medical electronics, software and regulatory expertise, so your device is not only cutting-edge but compliant with medical standards.
IEC 62304, ISO 13485, human factors — we've taken devices through the regulatory process enough times to know where products usually get stuck, and design around it from day one.
We develop custom electronics and embedded systems designed for precision, safety and long-term reliability, ensuring compliance with medical standards.
We build embedded and application-level medical software that complies with IEC 62304, ISO 13485 and FDA software validation requirements.
We integrate AI-driven decision-making into medical devices for predictive diagnostics, real-time monitoring and automated analysis, for faster and more accurate clinical insight.
We develop and test functional prototypes to validate design decisions, ensuring reliability, safety and manufacturability before regulatory submission.
We apply human factors engineering so devices are easy to use, minimise risk and comply with usability standards (IEC 62366-1).
We design wireless medical devices that comply with cybersecurity and patient data protection standards, for reliable and secure data transmission.
Bringing a medical device to market requires strict adherence to FDA, MDR, UKCA and ISO 13485. We integrate compliance into every stage of development.
Prototypes in weeks, approvals in months. Three recent examples.
Tell us where you are in the process. We can join at any stage, from conception to launch.
