Medical Firmware and Device Connectivity

Camgenium’s Foundation 2a platform is a pre-validated regulatory compliant software infrastructure for MedTech innovators to build class IIa / IIb medical devices. This next-generation medical firmware seamlessly provides the necessary foundation layer for building any compliant class IIa medical device. Camgenium's Foundation 2a platform delivers an 'out-of-box' medical compliance solution for MedTech innovators. The solution is cloud enabled with sophisticated micro-service technology and can rapidly create a digital twin of your medical device.

When developing new medical device products, engineers have an ethical as well as legal obligation to ensure the device is built to standards. Camgenium's Foundation 2a platform enables innovators to build ethical, regulatory compliant medical devices that are safe and trusted. Foundation 2a is an extensive and flexible communications platform designed for medical device use. It is highly secure and resilient and meets international regulations for medical devices and information security. Its complex security compliance requirements meet IEC 62304, IEC 81001-5-1, FDA and EU MDR standards.

The Foundation 2a platform enables innovative healthcare solutions to no longer remain concepts but become a reality. This pioneering technology will bring new medical devices to market sooner and removes the barriers many MedTech innovators face when it comes to high development costs and regulatory expertise.

Camgenium has over 17 years of expertise in building regulatory compliant medical devices for our clients. Camgenium's Foundation 2a platform minimises risk, accelerates development time and reduces cost with its class IIa critical care standard, compliant software. The platform provides the first necessary layer of firmware, technical file preparation and submission to enable the development of any medical device up to class IIa. Camgenium can manage all regulatory responsibilities from technical file preparation and submission to EU MDR 2017/745 compliance documentation, monitoring and surveillance.

Medical devices built on Camgenium's Foundation 2a layer will meet 100% compliance against all applicable security standards. The pre-existing medical firmware and cloud platform developed by Camgenium eliminates months of development and validation time. This allows our expert team of engineers to build new medical devices significantly faster compared to other service providers starting the development from scratch. Foundation 2a is supported by full documentation evidence meeting the necessary medical device development requirements. Innovators who use the Foundation 2a platform dramatically accelerate and de-risk connected medical device development. The platform removes the need for large additional human resources with specialist medical device expertise. Camgenium will meet all regulated safety and performance criteria for you.

Once your medical device has been developed and is ready to be brought to market, the standards state manufacturers still require ongoing surveillance and monitoring to remain fully compliant. Failure to do this can result in stringent penalties by the authorities. Camgenium not only offers software services to develop your new medical device rapidly, we can also provide continuous support throughout the product lifecycle. To continue to meet the medical device compliance standards, developers must be able to provide real-time security monitoring, threat detection and post-market surveillance. Camgenium provides a full Software as a Service ( SaaS) offering so you can focus on commercialisation, and our experts can manage the stringent regulatory requirements.

Camgenium provides the toolkit to empower MedTech innovators to develop new classes of medical devices. Meeting the security requirements of multiple standards necessary for class IIa / IIb devices is complex and requires a deep understanding of embedded and platform security. Camgenium's Foundation 2a platform offers the first stage of regulatory compliant development for you. The platform includes ultra-low power operation which allows easy development of battery-powered BLE and Wi-Fi 6 devices. Its smart BLE out-of-band communication is a game changer for devices that need to send large data, like waveforms or images, whilst operating continuously on battery power.

Ultra-low power smart devices can be distributed around a patient’s body forming a resilient personal network with a micro-hub that connects to the Camgenium medical cloud via a single higher bandwidth connection like Wi-Fi, cellular or LoRa. Foundation 2a also supports secure, confidential and resilient mesh networks across multiple patients and instruments in a ward, between hospitals and in patients’ homes.

Camgenium's team of engineers are expert with the latest technologies and development processes. Our team can build ultra-rapid custom applications, including patient and clinician apps as well as advanced AI/ML development. Custom apps can be added to your medical device utilising Camgenium's wider platform portfolio. We develop richly featured custom patient and clinician apps as well as device management solutions.