The regulatory pathway for medical device software or software as a medical device (SaMD) is not always straightforward. Being 100% medical-focused, we understand software regulatory requirements. Whether you are looking to build an app or embed software into your product, our experienced engineers can work with you to get your idea to market and help you through medical software regulations to achieve a compliant medical device.
Our projects span a wide variety of devices from critical liver perfusion devices to sensors to track device compliance. Our software consultants understand that the demands of each development project are unique.
Our team has a wide range of expertise and can help you develop embedded software on bare metal without an operating system, using a Real Time Operating System (RTOS), or on an operating system such as Linux. Everything is done to match and optimise software to your system’s requirements and reduce time to market.
Software can be the medical device itself, whether it is running on mobile devices, PCs, or cloud servers. Software as a Medical Device (SaMD) follows the development pathway outlined in IEC 82304. We work with you to meet regulatory requirements and ensure you have the smoothest possible development cycle.
We apply our high development standards to make your applications safe, reliable, and compliant with regulatory requirements.
Medical software needs to achieve the level of user experience expected of consumer products. This is why our software consultants work closely with our UI/UX designers to ensure your applications meet your medical device needs, your users’ expectations and comply to regulatory
standards.
The safety of your device is crucial. Your software is tested, maintained, and evaluated using advanced toolsets such as automated testing, from the very start of your project. This enables continuous regression testing, allows us to create safe and high-quality code throughout the development life-cycle, and ultimately reduces time to market.
We help you navigate the meaning of standards like IEC 62304 and work with you to develop safe, maintainable software.
Risk management is an integral part of your software development. Our process is aligned to ISO 14971 and we apply specific risk management and evaluation techniques described in IEC/TR 80002-1 throughout your device’s life cycle.
We make our workflow flexible by following an Agile development life cycle, using guidance from TIR45 to meet the expectations of IEC62304, saving you time to market.
From drug delivery, diagnostics and MedTech to critical care, our team ensures that your software is of the highest quality and developed to the latest regulatory standards for the worldwide market. Here are some services that our clients come to us for:
