Medical device firmware services for compliant & connected devices
Build, modernise, or scale your firmware so it’s secure by design, audit-ready, aligned with global medical device standards (such as IEC 62304 and ISO 14971), enabling compliance with MDR and FDA.
Why do medical device companies work with us?
As a critical supplier, we support medical device companies in developing solutions that comply with regulatory requirements (e.g., IEC 62304, ISO 14971), system architecture, and real-world device constraints.
This means your firmware is developed with MDR compliance, traceability, and risk management built in from the start, supporting audit readiness and avoiding late-stage redesigns.
Common firmware challenges
Firmware developed without traceability
Legacy firmware is limiting MDR transition or product scaling
Communication gaps between hardware, firmware, and connected systems
Cybersecurity was introduced too late in development
Missing or incomplete documentation is required for certification
Unsafe or unmanaged software updates
Firmware not aligned with IEC 62304
Firmware development
Get market-ready firmware tailored to your medical device and real-world conditions with full traceability across requirements, code, and testing. Support seamless data processing, accurate sensor integration, secure device connectivity, and a scalable architecture prepared for audits and long-term product lifecycle management.
We design and develop embedded firmware with a focus on real-time processing, firmware risk management, and robust system architecture. Our work includes hardware and software communication, implementation of data processing pipelines, and secure integration with cloud platforms.
Legacy firmware refactor
Reduce firmware compliance issues and modernise your MDD legacy firmware into a maintainable architecture that meets MDR requirements and certification, while preserving verification and validation integrity.
We analyse and refactor existing firmware to improve architecture while maintaining validated device behaviour and system integrity. This includes codebase restructuring, unit testing, CI/CD implementation, and toolchain updates, while meeting IEC 62304 and ISO 14971 requirements.
Supporting capabilities
Seamless device connectivity
AI-powered embedded solutions
Cybersecurity & data privacy
Firmware compliance solutions
Seamless device connectivity
Facilitate secure connectivity between your device, cloud, and mobile apps. Support seamless data exchange, remote device management, and scalable communication.
We design and implement connectivity solutions for embedded devices, including reliable device-cloud communication, mobile integration, and OTA (over-the-air) updates, supporting system integration.
AI-powered embedded solutions
Extend your medical device capabilities with AI. Turn collected data into new features, advanced insights, and smarter product decisions.
Leverage real-world usage data to continuously improve your device, better understand how it is used in practice, and identify opportunities to optimise performance and reduce production costs. Strengthen your product’s competitiveness by evolving it beyond hardware limitations through scalable, data-driven intelligence.
Cybersecurity & data privacy
Build firmware with cybersecurity embedded from the start, reducing device-level risks and supporting safe product operation.
We implement firmware-level security and privacy mechanisms such as secure boot, encryption, authentication, and secure updates aligned with regulatory expectations.
Firmware compliance solutions
Ensure compliance with international data protection, cybersecurity, and risk management standards, as well as EU MDR requirements, without slowing down development.
Our processes are designed in line with IEC 62304, ISO 14971, and MDR requirements. Enabling end-to-end traceability, structured technical file and audit documentation from the very beginning, and readiness for certification.
Schedule a consultation
to discuss your firmware development or refactor scenario.
What you get working with us
Reduced certification risk and faster time to market
Market-ready firmware built for real-world conditions
Firmware developed with IEC 62304 and MDR requirements
Safe connectivity achieved through a cybersecurity-first approach
Firmware is designed as a part of the full ecosystem
Support across the entire product lifecycle
How we support you as a critical supplier
We act as your critical supplier, delivering firmware and documentation aligned with your quality and regulatory framework, while you remain the legal manufacturer responsible for the device. This ensures consistency with regulatory requirements, improves traceability, and reduces compliance risks across the software lifecycle.
Case Study
About Revolve Healthcare
A firmware & embedded partner for reliable, audit-ready medical devices
We provide medical device firmware services, helping companies design, develop, and modernise firmware for connected devices. By combining embedded engineering with regulatory expertise, we support the creation of market-ready firmware, the improvement of legacy systems, and preparation for MDR certification. Cybersecurity, connectivity, data privacy, and regulatory requirements are integrated into a cohesive development approach.
Operating within an ISO 13485-certified QMS, we use our Agile 62304 framework to align development activities with IEC 62304, ISO 27001, ISO 14971, and IEC 62366. Our team has contributed to more than ten MDR- and IVDR-aligned software projects, covering both end-to-end product development and legacy system refactoring.
Build, modernise, or scale your medical device firmware with confidence.
During a free 45-minute call you will:
clarify your current firmware development challenges,
identify risks related to performance, cybersecurity, and compliance,
explore how to improve reliability and scalability,
get expert guidance on your further development.