Medical-device software
Software for medical devices, built to pass.
We build the software inside and around medical devices, firmware to cloud, to the standards your FDA or CE (MDR) submission demands.
Book a 30-minute call- 10+ yrs
- in safety-critical software
- FDA / CE
- submission-ready evidence
- 100%
- test coverage achievable
What we build
One team for the whole device.
From the electronics and firmware to the apps and the cloud, every layer built and tested by one team.
Firmware
Embedded software on the board, controlling the hardware safely in the field.
Electronics
The board and hardware your device runs on, designed and built right.
Real-time
Time-critical control and safety logic, predictable under real-world load.
Connectivity
Secure links between the device, the apps and the cloud.
Apps
The PC, web and mobile apps clinicians and operators use.
Cloud
Cloud services and data, so devices report, update and scale.
Proven
Trusted by medical-device companies.
We have built software and electronics for medical-device makers whose products cannot fail, from a regulated drug-infusion pump to catheter-based and implantable devices.
and more.
Built for scrutiny
What reviewers require, and what we deliver.
Medical software is held to a higher bar. We build the evidence your FDA 510(k) or CE (MDR) submission and ISO 13485 quality system need, from day one.
IEC 62304 lifecycle
A documented software lifecycle, planning through verification, the way FDA and CE reviewers expect.
Requirements traceability
Every requirement linked to the code and the tests that prove it.
Static analysis & MISRA
MISRA and static-analysis checks with tools like Parasoft C/C++test, Axivion and Klocwork, so risky constructs are caught before they ship.
ISO 13485 evidence
Design records and documentation that slot straight into your quality management system.
Coverage
Code coverage to the right level.
We match coverage to your device’s safety classification, using the right tool for your project.
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MC/DC
Highest rigour, for the strictest classes
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Decision
Every branch taken
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Statement
Every line executed
Among the coverage tools we work with
From open-source gcov to Tier-1 certified tools like Cantata and Testwell CTC++. These are examples, not the full list. We use whatever your project needs.
How we work
From first call to a device you own.
A clear path from first call to a device ready for review.
Discovery
We learn your device, timeline and regulatory path.
Architecture
We map the software and the IEC 62304 lifecycle around it.
Build & verify
We build, test and measure coverage, with traceability.
Handover
Full source, tests and the complete evidence package.
What you get
Audit-ready, from day one.
The evidence, tests and documentation an assessor expects, prepared as we build, not reconstructed at the end.
On quality
What medical-device software quality really takes.
Quality in safety-critical software is not one tool or one test, it is how the whole process fits together. Our founder, Eyal Gerber, broke this down in a talk at MDI Expo 2026.
What the talk covers
- Where quality gaps come from
- Real-world failures, and their root causes
- Static analysis and unit testing
- Code coverage and architecture
- CI/CD and automation
- Where AI fits in embedded software
Building a medical device? Let’s talk about the software.
Book a 30-minute call