Industries
Embedded engineering for medical devices and systems
Firmware, electronics and connectivity for diagnostic, monitoring and therapy devices - with the documentation, risk management and security that medical device regulations expect.
Sector challenges
Regulated software lifecycle
Medical device software follows IEC 62304: requirements, architecture, verification and traceability are part of the work, not an afterthought.
Risk management
Hazards are analysed with your team according to ISO 14971, and the risk controls end up in the firmware and hardware design.
Safety and reliability
Devices must behave predictably: watchdogs, safe states and tests on real hardware in our lab.
Cybersecurity
The EU MDR and the FDA expect security for the whole lifecycle: secure boot, signed updates and an SBOM - see secure boot and OTA.
Our approach
- 01
Requirements and risk
Software requirements and risk controls defined together with your quality and regulatory team.
- 02
Design and implementation
Documented architecture traced to requirements. See firmware development and hardware & PCB design.
- 03
Verification
Unit, integration and hardware-in-the-loop tests with records you can use in your technical documentation.
- 04
Maintenance
Secure updates, monitoring of third-party software (SOUP) and change control for devices on the market.
What we deliver for your technical documentation
- Software requirements and architecture descriptions
- Traceability from requirements to tests
- Test plans and reports, including tests on target hardware
- SOUP list and SBOM with vulnerability monitoring
Case
Stack
Firmware
- C / C++
- RTOS
- Embedded Linux
Connectivity
- BLE
- Wi-Fi
- USB
Standards we work with
- IEC 62304
- ISO 14971
- IEC 81001-5-1
FAQ
Discuss your project
Describe your device and goal. An engineer replies within one business day.