Industries
Software for medical technology, laboratory and analytical technology
In medical technology, software is part of the product and therefore part of the evidence requirements. SABO IT develops modules and service and diagnostic tools for medical and laboratory devices, in compliance with EN IEC 62304, DIN EN 60601-1 and FDA requirements. For manufacturers such as Maquet and Kirsch.
Challenges
Typical challenges
Every change needs a chain of evidence
Development, changes and testing must remain traceable across the entire product life cycle — even years later, even when the people involved are no longer with the company.
Safety-relevant devices run in isolated environments
Wired, without an internet connection, with separate roles for service and production. Tools that weaken this separation don’t make anything easier.
Equipment from different manufacturers needs to work together
Lights, cameras, climate control, analyzers and controls each come with their own protocols. Bringing them together in one interface without increasing dependence on any single piece of hardware is the real task.
Services
What SABO IT develops for medical technology, laboratory and analytical technology
Modules for existing devices
For Maquet’s Tegris operating room system, we were responsible for entire modules: from requirements specification through integration of external hardware and software to the user interface, backed by automated tests.
Service and diagnostic tools
For Maquet, we built the service box for the Rotaflow Drive II: service technicians use it to set and read out drive parameters, run service and production tests, and install firmware updates. The application works exclusively over a wired Ethernet connection, with no internet connection.
Monitoring and documenting device fleets
For Philipp Kirsch, we built the Evolution Cloud: an IoT platform for monitoring and managing refrigeration units for laboratories and medicine. Temperature histories and device states can be viewed across locations: the basis for any documentation that has to hold up in an audit.
Testing as part of development
Automated test strategies, including hardware-in-the-loop and backward compatibility, integrated into a CI/CD pipeline. This is the prerequisite for short development cycles in an environment that expects every change to be documented.
Customer testimonial
“We chose SABO because they can quickly acquire the necessary knowledge of the application domain, and because they have a strong sense of quality and a clear commitment to delivering results without generating administrative overhead. SABO fully met our expectations and delivered their services to our complete satisfaction.”
Michael Mankopf · Vice President Marketing, MAQUET Surgical Workplaces
References
References from medical technology, laboratory and analytical technology
Maquet Tegris
Module development for the operating room
Maquet Rotaflow Drive II
Service box for a life support system · 2022–2024
Kirsch Evolution Cloud
IoT platform for refrigeration units in laboratories and medicine · 2022
About us
Why SABO IT
For us, regulated development isn’t a special case: we’ve worked for years in environments where every change has a chain of evidence. Documented decisions, automated tests and software that stays maintainable after go-live belong together for us. More than 60 IT professionals, software development since 1983, as SABO IT since 2012.
Let’s talk about your device
Whether a module needs to be integrated into an existing system, a service tool developed or a device fleet monitored — we clarify the evidence framework first, then the technology.
FAQ
Who develops software for medical devices in compliance with EN IEC 62304?
SABO IT develops software for medical and laboratory devices in compliance with EN IEC 62304, DIN EN 60601-1 and FDA requirements. For Maquet, SABO IT was responsible for entire modules of the Tegris operating room system — from requirements specification through integration of external hardware and software to the user interface.
What does DIN EN 60601-1 mean for software development?
DIN EN 60601-1 governs the safety of medical electrical equipment. For software, this means it is part of the device and is assessed together with it. Risk assessment, evidence and testing therefore belong in development, not in a later phase. SABO IT develops on this basis; the manufacturer carries out the device’s conformity assessment.
How are service tools for medical devices developed?
In isolated environments and with separate roles for service and production. For Maquet, we built the service box for the Rotaflow Drive II: service technicians use it to set and read out drive parameters, run service and production tests, and install firmware updates. The application works exclusively over a wired Ethernet connection, with no internet connection.
Who is responsible for MDR compliance, the manufacturer or the service provider?
The manufacturer. The manufacturer is always responsible for the MDR compliance of the finished medical device, even when parts of the software are developed externally. SABO IT develops in compliance with EN IEC 62304 and DIN EN 60601-1 and provides the development documentation the manufacturer needs for this. SABO IT does not replace a legal or regulatory assessment.
How do you monitor device fleets in laboratories and medicine?
With a platform that brings device states and histories together across locations. In 2022, we built the Evolution Cloud for Philipp Kirsch: an IoT platform for monitoring and managing refrigeration units for laboratories and medicine. Temperature histories and device states can be viewed across locations — the basis for any documentation that has to hold up in an audit.