Development of a data display for use in medical radiation therapy to visually verify the position of moving components and display user-relevant messages.
Medical technology requires software development
Medical Software Engineering represents the structured, safe, and standards-compliant development of software for medical devices and systems. It goes far beyond ensuring basic functionality: in the medical technology sector, safety, reliability, and adherence to regulatory requirements are paramount.
Particularly for medical devices, expectations for risk management, documentation, and traceability are exceptionally high. Standards such as IEC 62304 (software life-cycle processes) and ISO 14971 (risk management) form the foundation of a professional and auditable development process.
Software embedded in medical devices must demonstrably be stable and safe—because in critical situations, human health and lives are at stake. Robust Medical Software Engineering is therefore a decisive factor for successful market approval, regulatory compliance, and long-term product accountability.
Reliable software development relies on structured processes
As specialists in Medical Software Engineering, we support manufacturers, from the initial concept for their system, all the way to series production
Requirements Analysis
We define IEC 62304-compliant software requirements, support creation of the functional specification, and ensure full traceability.
Architecture & Design
We develop modular, maintainable architectures tailored to embedded systems, PC applications, or cloud-based solutions.
Implementation
We develop software in C, C++, C#, Python, and Java, combining modern engineering practices with strict quality and regulatory standards while following clean code and agile principles.
Verification & Validation
Our testing strategy covers modules, integrations, and full systems, complemented. Reviews, traceability and coverage are integral parts of our approach.
Documentation & Approval
We deliver comprehensive technical documentation and support regulatory audits and submissions.
Agile Development
Even in the structured world of medical software development, documentation, and testing, we work agile. From day one, we ensure transparency, clear development progress, and immediate stakeholder feedback — following Act, Inspect, Adapt to drive continuous project success.
Our Approach: Structured, Safe and Efficient
Technology Stack
Our projects are built on proven technologies, including:
- C/C++ for medical device software
- .NET / C# / Angular / WPF / Qt for graphical user interfaces
- Python / Java / Node.js for backend components and data analysis
- Docker / Azure / AWS for scalable cloud solutions
- Git / Polarion / Jenkins for version control, CI/CD, and ALM
Why Coose US
For over 30 years, we have supported medical technology companies in delivering safe, high-quality software.
Our core strengths:
- Hands-On Consulting – with a clear focus on time-to-market
- Expert Knowledge – expertise across multiple medical domains
- Regulatory Expertise – fluent in Notified Body requirements
- Certified Quality – ISO 13485 und ISO 9001
- Long-Term Partnerships – ensuring clarity and long-term reliability
Your Project – Our Responsibility
Whether you are just starting product development or modernizing an existing system:
we stand by your side as a trusted and competent partner.
What we have realized for our customers
DICOM for a 3D surgical microscope
Development of a DICOM solution for a digital surgical microscope from a leading German manufacturer: Loading, categorizing, ordering, and sorting DICOM data Display of DICOM images in their original format…
DICOM interface for X-ray machine
A manufacturer of an innovative X-ray machine commissioned us to develop a DICOM interface for integration into the clinical workflow: New development based on .NET Various service classes and relevant…
Integration of operating table and risk analysis
A leading manufacturer of operating tables commissioned us to integrate an operating table into an existing system. The content of the project was: Concept, taking functional safety into account Risk…
