Medical device firmware, built for the submission, not just the bench.
IEC 62304-aligned process, ISO 14971 risk management, fail-safe firmware patterns and HIPAA-relevant data handling — for wearables, patches and other connected health devices.
Medical device firmware development
Firmware built with the regulatory path in view from day one, not retrofitted before a submission.
- IEC 62304-aligned software lifecycle
- ISO 14971 risk management
- Fail-safe firmware patterns (watchdog, self-test, NVM state)
- HIPAA-relevant data handling, on-device and in-cloud
- Bare-metal & RTOS firmware for physiological sensing
- Embedded Linux for hub- and console-class devices
- BLE 5.x connectivity for companion apps
Where AI accelerates
- Driver & protocol stack boilerplate
- Requirements-to-code traceability scaffolding
- Unit test scaffolding
- Log/telemetry formatting code
Where it stays human
- Risk classification & hazard analysis
- Fail-safe threshold and watchdog tuning
- Security architecture for PHI
- Verification evidence sign-off
What actually shapes medical device firmware.
Regulatory process, not just paperwork
IEC 62304 governs the software development lifecycle for medical device software, with process rigor scaled to safety classification and forward traceability required from requirements through design, code and verification evidence. ISO 14971 covers risk management — hazard identification, risk estimation and controls — extended for connected devices to firmware bugs, connectivity loss, cloud outages and cybersecurity threats.
HIPAA-relevant data handling
Any cloud, infrastructure or analytics vendor touching PHI needs a Business Associate Agreement in place. PHI in transit uses TLS, not a legacy or proprietary protocol; PHI at rest — on device, in transit queues, in cloud databases — stays encrypted, with role-based access control scoped to minimum need and audit logging of PHI access at the platform layer.
Fail-safe firmware patterns
A hardware watchdog timer resets the device on a firmware hang. Periodic self-tests check sensor plausibility, battery/storage range and wireless-stack liveness. Critical state — current session, last N readings, calibration data — is written to non-volatile memory frequently enough to survive power loss, structured to avoid mid-write corruption.
What the hardware and firmware look like in practice
Our fall-detection wearable pairs an IMU with a Cortex-M-class MCU running on-device inference, holding sub-second detection latency and sending only classified events over BLE, not raw motion streams. Our vitals patch combines a Cortex-M-class MCU with an analog front-end for ECG/PPG-class sensing, an RTOS-based scheduler separating sampling, radio and power-state duties, a BLE 5.x link to the companion app, and REST/HTTPS for the device-to-cloud hop.
Real builds in health and medtech.
Pulled from our case-study library — same AI/human split shown in full, industry context included.
On-Device Early Fall-Detection Wearable
US-based aging-in-place / digital-health wearable startupA wearable continuously analyzes motion data locally to identify movement patterns associated with potential falls, without continuously transmitting raw sensor data to the cloud.
Remote Patient Vitals Patch
US-based digital-health / remote-patient-monitoring startupA wearable medical patch continuously captures patient vital signs and securely transmits physiological data for remote monitoring.
AI-Personalized Wearable Sleep Coach
US-based digital-health / consumer wearable startupA wearable tracks sleep-related physiological signals and delivers personalized coaching based on on-device and cloud analysis.
Read full case study →What people ask before scoping medical device firmware.
Do you develop firmware to IEC 62304?
We build our process aligned to IEC 62304's software development lifecycle, with process rigor scaled to safety classification and forward traceability from requirements through design, code and verification evidence — so the work is ready to sit inside a formal submission when your regulatory path requires it. On hub- or console-class devices running embedded Linux, the kernel and userspace we don't author are treated as SOUP under the same lifecycle — identified, version-pinned and carried into the risk analysis rather than assumed safe.
How do you handle risk management for connected devices?
ISO 14971 risk management — hazard identification, risk estimation and controls — extended for connected devices to firmware bugs, connectivity loss, cloud outages and cybersecurity threats, not just the mechanical/electrical hazards a standalone device would face.
What fail-safe patterns do you build into medical firmware?
A hardware watchdog timer resets the device on a firmware hang. Periodic self-tests check sensor plausibility, battery/storage range and wireless-stack liveness. Critical state is written to non-volatile memory frequently enough to survive power loss, structured to avoid mid-write corruption.
Can you handle HIPAA-relevant data on the device and in the cloud?
Yes. PHI in transit uses TLS, PHI at rest stays encrypted on-device, in transit queues and in cloud databases, access is role-based and scoped to minimum need, and PHI access is audit-logged at the platform layer. Any vendor touching PHI needs a Business Associate Agreement in place.
Do you handle the hardware for the medical device too?
Yes — schematic capture, PCB layout and analog front-end design for physiological sensing sit in the same engagement as the firmware, so power, timing and fail-safe decisions get made together.
Medical device firmware rarely ships alone.
Medical Device Development Company
The broader case for one team across medical device engineering.
Medical IoT & Connected Medical Devices
Our full industry page on connected health device development.
Wearable Medical Device Development
Form factor, power budget and on-body sensing, specific to wearable medical devices.
Embedded Firmware Development
Hardware and firmware scoped together, in one combined overview.
Cloud & Device Platforms
Data pipelines from device to storage, with compliance considered at every hop.
IEC 62304 Safety Classification
Field Notes article on classifying medical device software safety.