Software for devices that have to be right.
Firmware, connectivity, companion apps and software as a medical device, developed under IEC 62304, documented for your technical file and delivered inside your quality management system.
What we hear before a project starts.
“Our hardware is ready, the software and the documentation are not.”
“The notified body asked for the software lifecycle evidence.”
“We need a companion app, a cloud backend and cybersecurity, from one partner.”
From firmware to the technical file.
Embedded & firmware
C/C++ and Rust firmware on ARM Cortex-M and Linux targets, sensor acquisition, BLE and cellular connectivity, OTA updates, power management and bench testing. Electronics design and manufacturing with hardware partners.
SaMD & companion apps
Mobile and web applications that display, compute or transmit medical data: patient and HCP apps, remote monitoring, integration with EHR and device clouds (HL7 FHIR, DICOM where relevant).
Proof. DiabApp for Action Diabète Valais, CardioRisk.
Device cloud & data platform
Secure ingestion, device fleet management, dashboards, alerting, data retention rules, Swiss or EU hosting.
Regulatory software lifecycle
Safety classification (A/B/C), development plan, requirements and architecture, risk management file, verification and validation, SOUP management, traceability matrix, cybersecurity file (IEC 81001-5-1) and usability engineering support (IEC 62366-1), inside the manufacturer’s ISO 13485 QMS.
Connected products beyond medical
Industrial IoT, wearables, smart building and tracking.
Proof. GPS point-gathering technology (Africa Telecom People Award), iBeacon and sensor projects, facial recognition.
In a medical device, what measures, alarms or doses is deterministic.
AI, when used, sits in a separate, clearly bounded component with its own risk analysis, validation dataset and monitoring. We design that boundary with you and document it for the technical file.
How we work with your quality system.
Your device, your classification and your constraints.
Classification, architecture, plan and estimate.
Design reviews and verification evidence at each sprint.
The software part of your technical file.
Updates, vigilance support and cybersecurity patches.
Selected work, further references available under NDA
Three ways to start.
Fixed price, quoted after the free audit.
Software regulatory audit
2 weeks · Fixed priceGap analysis of an existing software against IEC 62304, with an action plan.
Companion app MVP
10 to 14 weeksApp, backend and the documentation set.
Device software team
MonthlyA dedicated squad with QA and documentation.
Medical device software, answered
Which software safety class can you handle?
Classes A and B, and class C together with the manufacturer’s clinical and regulatory partners.
Do you provide the technical documentation?
Yes, the software part of the technical file.
Can you work on an existing codebase?
Yes, after a regulatory audit of the software and its documentation.
Do you build the hardware?
With partners. We own the software and the integration.
Where is the data hosted?
In Switzerland by default, or in the EU or your own infrastructure on request.
Let’s start with one hour.
In a free one-hour audit we map your three most valuable use cases, the constraints on your data and a realistic budget and timeline. No slides, one senior engineer.