Solutions /
Medical Devices
BootLoop connects device requirements to repeatable tests of firmware, sensors, alarms, power, connectivity, and recovery behavior, producing structured evidence on the hardware patients and clinicians depend on.
The problem
Medical device behavior depends on interactions between firmware, sensors, actuators, batteries, accessories, and connected systems. As software and hardware change, teams must repeat large validation cycles manually—while requirements, test procedures, and execution evidence remain difficult to keep aligned.
With BootLoop
BootLoop turns requirements, hazards, schematics, datasheets, and expected behavior into repeatable tests executed on real devices. The hardware-aware agent accelerates firmware and test development, while structured results show exactly what was tested, on which configuration, and how the device responded.
Workflow
STEP 01
Model the device, its risks, and its interfaces
Bring in requirements, risk controls, schematics, datasheets, accessories, and expected operating states. BootLoop organizes them into a hardware-aware foundation for testing sensors, alarms, actuators, power, communications, and firmware behavior.
STEP 02
Generate and execute risk-based hardware tests
Connect the device, accessories, fixtures, and instruments. Generate tests with the agent or codify approved procedures to exercise boundary conditions, invalid inputs, power loss, connectivity failures, alarms, safe states, and recovery behavior.
STEP 03
Preserve evidence across the product lifecycle
Run repeatable tests throughout development, capture configuration-specific results, and reuse proven coverage after firmware, component, or manufacturing changes. Turn complaints and resolved defects into lasting regression protection.
One validation record for engineering and quality
Firmware, systems, V&V, quality, and manufacturing teams should not maintain separate accounts of device behavior. BootLoop keeps requirements context, test definitions, device configurations, and results together so evidence can be reproduced and reviewed across the product lifecycle.
Risk controls connected to repeatable real-device tests
Shared evidence across firmware, V&V, quality, and manufacturing
Resolved complaints become permanent regression coverage
Field note
Every risk control should be backed by device behavior your team can reproduce.
Built for device validation teams
Medical devices
Linked to real-device testing
Traceable execution evidence
Reusable lifecycle coverage
Get started