expertise
Medical Device Software Development
We specialize in embedded software and SaMD development, combining engineering excellence with deep regulatory knowledge. Trust experts and develop your medical device according to IEC 62304.
Get expert support for medical software development
- Access skilled software engineers for both embedded and SaMD projects
- Accelerate delivery without compromising quality of regulatory compliance
- Receive IEC 62304-ready code and documentation
- Delegate software architecture and cybersecurity documentation and get FDA + MDR clearance
MEDICAL SOFTWARE CASE STUDY
Bio-Rad Laboratories
See how five Somco engineers spent two years rebuilding the architecture of Bio-Rad's PCR|ONE diagnostics platform so multiple devices could work together as a single cluster.
What we can do for you?
Here are some examples of types of projects we could work on together
Software in a Medical Device
You get a complete embedded medical solution - firmware, GUI, and connectivity - ready for real-world use and certification.
IoT Solutions for Healthcare
You get smart, connected healthcare devices - like wearables or meters - that integrate with apps and medical systems.
Software as a Medical Device
You get flexible, accessible medical software - delivered as desktop or web apps for professionals and patients alike.
Why Somco Software for medical device software development?
ISO 13485 certified partner
You simplify your certification process by partnering with an ISO 13485-certified, audit-ready software team.
Medical features experience
You get experts ready to handle key medical software features like DICOM, PACS, HL7 FHIR and connectivity.
Support in regulatory
You get software and documentation aligned with IEC 62304:2006, ready for a smooth regulatory process.
Unique embedded expertise
You benefit from end-to-end embedded expertise - from prototyping to GUI on validated embedded hardware.
Cybersecurity expertise
Somco Software handles topics like threat modelling, vulnerability assessment, SBoM, and much more.
What medical software have we developed for our clients?
Why Qt for medical software development?
While we’re skilled in technologies like LVGL, C#, and modern web frameworks, Qt remains our preferred choice for many projects.
Outstanding performance
Qt has a core based on efficient and popular C++ language. Thanks to it, the performance and security of applications is significantly increased and developers can connect other, external libraries based on C++.
Ready-made modules to speed up medical software development
Qt contains numerous ready to use functionalities like advanced networking, 3D models, Safe Rendering and many other, that can be integrated with the existing code in a childishly easy way.
Meets medical certification standards
Qt Safe Renderer module has been deemed suitable for life-sustaining and life-saving devices. TÜV NORD has confirmed that Qt Safe Renderer meets the requirements of the following standards: • IEC 62304:2015 • IEC 61508:2010 • ISO 9001:2015
Rapid and effective development process
Qt enables fast, high-quality development thanks to its mature tools, cross-platform nature, and powerful QML/UI framework. It lets us prototype quickly, reuse code across platforms, and deliver polished results with shorter time-to-market.
Cross-platform
You can use the same codebase to generate ready to use applications for many, different devices: Windows, iOS, Android, Linux, or embedded systems. This way you save a significant amount of resources while speeding up the software development process - no more hiring several, independent teams of developers.
What is most important to us in medical software?
01
Cybersecurity
We build secure medical device software by design - following IEC 62304, FDA Guidelines and industry best practices, with encryption, secure boot, and robust QA at every stage.
02
High performance
Our medical software delivers reliable performance for real-time tasks, using C++, Qt, and optimized architecture to meet strict clinical and hardware constraints.
03
Software architecture
We design maintainable, modular architectures that are documented according to IEC 62304 requirements. Our designs support automated testing, and ensure long-term quality and regulatory readiness.
Free Medical Software Course
Explore our materials for Medical Software Development
Discover a comprehensive course on creating medical software with Qt, a leading technology in the healthcare industry.
How the process works?
Fill out a form
After receiving the request, we will respond within one working day. We understand that time is crucial and we're responsive for you!
Introduction meeting
Our first meeting will be an hour-long introduction call. You will have the option to speak with our sales representative and a technical specialist during this conversation.
Analysis and proposal
According to the details that you presented to us during our first talk, we will either undertake an in-depth study of your case and recommend steps to take, or we will present you with an initial offer.
Dispelling doubts
We realize how important it is to select the right partner for your project. You have the option of screening us or our consultants to guarantee that you are partnering with true experts.
Contact us
Adam Sowa
Chief Technology Officer
Write a few sentences about your device and it lands directly in my inbox. We work under ISO 13485, so compliance and documentation are part of how we build, not an afterthought.
I usually answer within one business day.
Connect with me on LinkedIn