Medical Software Development
Standards-compliant software development for medical devices with C#/.NET
Medical Software According to IEC 62304
We develop medical software that is regulatory compliant from the start. With C#/.NET as the technical foundation and TÜV-certified expertise, we implement your project in full compliance with standards.
Our Range of Services
SaMD
Standalone Medical Device Software – independent medical software as a medical device.
DiGA
Digital health applications for BfArM listing with Blazor or .NET MAUI.
Companion Software
Software for controlling and monitoring medical devices.
Clinical IT
Modules for clinical information systems and data management.
Technology Stack
- ✓ C# / .NET 10 – robust, high-performance foundation
- ✓ ASP.NET Core – web applications and APIs
- ✓ Blazor – modern web frontends
- ✓ .NET MAUI – cross-platform mobile apps
- ✓ Azure / Cloud – scalable infrastructure
Regulatory Compliance
Every project is planned and documented in compliance with standards from the very beginning:
- ✓ IEC 62304 software lifecycle
- ✓ ISO 14971 risk management
- ✓ IEC 62366 usability
- ✓ SOUP management and cybersecurity
- ✓ Complete technical documentation for CE
The DiGA Market Is Growing
With over 59 listed DiGA in the BfArM directory and the Digital Act (DigiG), which extends the scope to risk class IIb, the DiGA market offers enormous potential. We support you on the path to a successful listing.