Medical device software has to be demonstrably safe – and every piece of evidence reproducible. Hardware-in-the-Loop (HIL) tests your device firmware automatically against a simulated environment: reproducibly, without risk to a patient or a real device, and with complete evidence for approval under IEC 62304. We tailor our compact HIL test platform LoopCheck to your medical device.
Your position in the 62304 space
We test the real device – and deliver the evidence
Code-level tools check the source code, consultants check the documentation. In between a gap remains: verification on the real medical device and the evidence for it. That is exactly what we close – with reproducible tests on the device and a chain of evidence that holds in an IEC 62304 audit.
Services
What you get
A test environment for your medical device
We build the test setup, connect it to your interfaces and put it into operation – matched to your safety class.
Test cases from your verification plan
Requirements become executable procedures at module, integration and system level, automated in your CI/CD.
Evidence for approval
Requirement, test case and result linked end to end – evidence that holds in an IEC 62304 audit.
Handover to your team
Documentation, onboarding, training. Your team runs the environment independently afterwards.
You would rather not build the test environment yourself? We take it on end to end, from analysis to handover.
Why HIL
Why HIL in medical technology?
Test safely – without a real device
Fault cases and edge conditions can be provoked deliberately, without damaging a real device or putting a patient at risk.
Reproducible verification
Every test run is bit-for-bit repeatable – the basis for dependable, auditable evidence.
Deliberate fault injection
Inject sensor, bus and timing faults on purpose to exercise the firmware’s safety and failure behaviour.
Evidence for IEC 62304
Requirements, test cases and results linked end to end – as evidence for verification.
Tools
What we test with
For Hardware-in-the-Loop we use our own platform LoopCheck, tailored to your medical device. For the documented system test on the finished device we add XPressRT. Where another tool fits better, we work with it.
References
Two independent laser projects
Two separate medical laser systems, both to IEC 62304 – tested reproducibly, without the real device.
Laser control, verified bit for bit
The signal side of the control verified bit for bit, with deliberate fault injection – entirely without a real laser system. Module and system tests automated in CI/CD, each run producing a reproducible record.
Device backend as a black box
The entire backend of controller and FPGAs tested as a black box: the device environment is simulated from the outside, the firmware runs against it and is checked against its specification – reproducibly, without a real device.
Reference project
Test environment for a medical device (IEC 62304)
For a safety-critical medical device with a controller and FPGA backend we built the module-test environments – for the QNX resource manager as well as for the FPGAs. We led the test team, established the test strategy and test automation, and describe the test cases in Gherkin/Behave so they stay readable to domain experts.
Services
What we cover
Module tests
Test individual components, drivers and control algorithms in isolation and repeatably.
Black-box system tests
Test the finished device through its real interfaces – the way it is used in the field.
Bit-exact bus verification
SPI, I²C, UART, CAN – protocol, payload and timing checked exactly, including fault cases.
Traceability & reports
Reproducible runs and dependable evidence – the evidence side of your verification plan.
Standard
IEC 62304 in practice
IEC 62304 defines the software life cycle for medical devices and requires – depending on the safety class (A, B, C) – documented verification at module, integration and system level. Automated HIL tests deliver exactly this evidence: reproducible, auditable and embedded in your V-model process. The specific safety class and the scope of evidence are agreed per project.
System test on the real device
And the documented test on the finished device
HIL verifies the firmware. On the finished device the documented system test is added: serial number, firmware state, measured value against limit, the instrument used with its calibration state, and the tester. The two mesh – the same requirement, two levels of evidence. That is what XPressRT is for. How the system test is documented to IEC 62304 in practice: documenting the medical device system test.
Frequently asked questions about HIL in medical technology
Does HIL replace the real medical device in testing?
For software verification, yes: the device firmware runs against a simulated environment that reproduces sensors, buses and peripherals. That lets you exercise fault cases and edge conditions without endangering a real device or a patient.
How does HIL help with IEC 62304 approval?
Automated, reproducible HIL tests provide the verification evidence that IEC 62304 requires – depending on the safety class (A, B, C) – at module, integration and system level, with end-to-end links between requirement, test case and result.
Can module tests and black-box tests be combined?
Yes. We cover module tests of individual components through to black-box system tests of the finished firmware – including deliberate fault injection.
Which interfaces are supported?
Fieldbuses and serial interfaces such as SPI, I²C, UART, CAN/CAN FD, Ethernet as well as analog and digital signals – bit-exact and with precise timing.
Verify your medical-device software on the real device
LoopCheck is our compact HIL platform, tailored to your medical device – reproducible verification evidence for IEC 62304, without a real patient device. If you would rather have the whole test environment built, we do that as a project.