End-to-End Embedded Software for Medical Devices
From BSP and drivers to UI apps and verification, aligned to IEC 62304 workflows to help you launch safer medical devices faster.
Challenges & Our Solutions
Regulatory Delays
Documentation gaps slow approvals and audits.
We build testable, traceable software with audit-ready artifacts.
Hardware–Software Integration
Unstable BSP/drivers and long bring-up cycles.
We stabilize BSPs, drivers, and bootloaders early to de-risk.
Limited Specialist Bandwidth
In-house team is stretched across platforms and protocols.
Add a timezone-aligned captive team for sustained velocity.
What We Deliver
Board Bring-Up & BSP
U-Boot, kernel patches, device trees, peripheral enablement.
Drivers & Middleware
Sensors, connectivity (BLE/Wi-Fi), storage, security primitives.
Application Layer
Qt/Android UI, workflows, alarms, data logging.
Verification & Validation Support
Unit/integration tests, CI hooks, traceability to requirements.
Documentation Package
SRS, SDS, test plans/reports, risk/issue logs—structured to fit IEC 62304 processes.
Maintenance
Patch management, CVE tracking, OTA update strategy.
Process for Regulated Teams
Requirements & Risk Alignments
Tie to your QMS process.
Architecture & Safety Class Mapping
Support for Class A/B/C systems.
Implementation & Continuous Testing
Iterative builds with integrated testing.
Verification with Traceability Matrix
Complete mapping of requirements to tests.
Release Package & Ongoing Maintenance
Final delivery plus long-term support.
Engagement Models
Fixed-Scope
POC or BSP stabilization packages.
Dedicated Team
Captive team with SLAs and sprint cadence.
Co-Development
Embedded alongside your QA/RA processes.
Frequently Asked Questions
Do you work within our QMS?
What standards do you support?
Can you handle BSP and app together?
What platforms do you cover?
Security & updates?
IP ownership?
