Medical device software built to a regulated bar
Software as a Medical Device (SaMD) and connected-device firmware engineered to FDA and IEC 62304 expectations — safe, documented, and auditable.
Where a bug isn't just a bug
Medical-device software carries a burden most software doesn't: it has to be safe, and you have to prove it. We build SaMD and connected-device software with the process, documentation, and rigor that regulated work demands.
- Software as a Medical Device (SaMD)
- Connected-device and IoMT firmware
- IEC 62304 lifecycle and FDA-aligned documentation
- Data pipelines, dashboards, and cloud connectivity
Engineering for regulated devices
SaMD Development
Diagnostic and therapeutic software built to standard.
Device Firmware
Reliable embedded software for connected devices.
IEC 62304 Process
A software lifecycle regulators recognize.
Cloud & Connectivity
Secure device-to-cloud data and remote updates.
Data & Dashboards
Turn device data into clinical insight.
V&V Documentation
Verification and validation you can submit.
Medical device software questions
Yes. We run a software lifecycle aligned to IEC 62304 with the documentation and traceability regulated submissions require.
We produce the software documentation, verification, and validation artifacts that support FDA submissions; we work alongside your regulatory team.
Yes — embedded device software plus the secure cloud, data pipelines, and dashboards around it.
Building a medical device?
Talk to a senior engineer about your SaMD or connected-device software.