Medical and health
Devices subject to audit. Firmware, update paths and production test developed to fit an existing quality management system.
Industries
Industries we work in
The silicon and the interfaces are broadly similar across domains. The requirements, the validation and the approvals are not. These are the ones we already know.
Automotive
CAN and LIN development against production vehicle equipment, retrofit electronics, and bench test systems.
Security and alarm
Long-life sub-GHz devices running from a single cell, and the production tooling required to build them in volume.
Industrial
Modbus, motor control, mains-borne signalling and analog instrumentation.
Sport and fitness
Connected equipment with sensor acquisition, wireless links and field updates.
Consumer wearables
Compact battery-powered devices with charging, low-power operation, pairing and mechanical constraints.
Regulatory scope
What we can and cannot certify
Medical and automotive projects are common here, and both involve certification a company of our size does not hold. It is better stated before a project starts than during it.
We develop the component, you hold the certification
Firmware, hardware and test tooling are developed to fit your quality management system. BrainIOStream does not hold ISO 13485 or ISO 26262 certification and does not act as the legal manufacturer of a regulated device.
Compliance is designed in from the start
Update paths, traceability and test evidence are built into the design rather than retrofitted into a finished product, which is the expensive route. We have taken firmware through FCC compliance.
Working in a domain not listed here?
Describe what the device has to do and the environment it has to operate in. Requirements transfer between domains more often than expected, and the constraint is usually the transferable part.