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.
ISO 9001:2015 certified · TÜV SÜD-certified tooling · ISO/IEC 62304 experience · founder built and sold a medical device (BiliCare)
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
Coverage, measured two ways.
Two questions decide whether your software is proven: is every requirement verified by a test, and is the code itself exercised. For a submission, the first often matters most. We measure and report both.
Requirements coverage
Every requirement, proven by a test.
The question your reviewer asks first: how many of the requirements are actually verified. We track it as a number, not a feeling, and link each requirement to the test that proves it.
- Each requirement traced to the test that verifies it
- Verification completeness tracked as a percentage
- A traceability matrix your FDA or CE reviewer can follow
Code coverage
And the code itself, to the right level.
We match code 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.
ISO 9001:2015 certified. An audited quality management system, scoped to software development per ISO/IEC 90003:2018. See the certificate
How we work
From first call to a device ready to ship.
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
Medical-device software questions.
Who builds FDA or CE submission-ready software for medical devices?
Novodes builds the software inside and around medical devices, firmware to cloud, to the standards an FDA 510(k) or CE (MDR) submission demands. Its founder built and sold a medical-device company, and it has delivered software for regulated drug-infusion pumps and implantable and catheter-based devices.
Does Novodes follow IEC 62304 for medical-device software?
Yes. We build a documented software lifecycle from planning through verification, the way FDA and CE reviewers expect, and produce design records and documentation that slot into an ISO 13485 quality system.
What evidence does Novodes provide for a medical-device submission?
We prepare the evidence as we build, not at the end: requirement-to-test traceability, unit and integration test reports, code coverage reports, static analysis and MISRA checks, and SRS, SDD and test documentation ready for an FDA or CE submission.
What code coverage do you achieve for safety-critical software?
We match coverage to the device’s safety classification, reaching Statement, Decision and, for the strictest classes, MC/DC coverage, using the right tool for the project (for example gcov, BullseyeCoverage, Cantata or Testwell CTC++).
Can Novodes provide requirement-to-test traceability for a medical device?
Yes. Every requirement is linked to the code and the tests that verify it, tracked as a percentage rather than a feeling, with a traceability matrix a reviewer can follow from requirement to test to result.
Does Novodes have a certified quality management system?
Yes. Novodes is ISO 9001:2015 certified, audited by IQC (the Institute of Quality & Control), with a scope covering software development per ISO/IEC 90003:2018 (certificate I33807A). A certified quality management system sits alongside the IEC 62304 and ISO 13485 work we do for medical-device software.
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