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.
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.
Case study: medical laser controller
For a medical laser controller we used LoopCheck to verify the SPI communication bit for bit and to inject faults deliberately – entirely without a real laser system. Module tests of individual components and black-box system tests of the finished firmware ran automatically in CI/CD, each run producing a reproducible record.
What we cover
What LoopCheck handles for medical devices
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.
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. LoopCheck covers 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.
HIL for your medical device – tailored by us
All the technical detail – hardware configurations, the Python API, architecture and a complete worked example – is on the LoopCheck platform.
- Verification evidence for IEC 62304 (class A/B/C)
- Module through to black-box system tests, automated in CI/CD
- Bit-exact bus verification and deliberate fault injection
- Tests in C, C++ or Python – no proprietary ecosystem