Solution
Medical Device Design and Engineering
Build your first medical device or modernize current one with trusted design and development partner.
Services covering the entire range
Our clients can choose between comprehensive or selective support throughout the entire medical device development process.
- Industrial design and research
- Graphical user interface (GUI) design
- Medical device software development
- Regulatory and cybersecurity
Our process
User research and requirements
Start with real user needs and clear requirements, with IEC 62304 compliance built-in from day one to reduce risk later.
Combined design
Unite industrial design, GUI, and sales and marketing visuals to create a device people trust, use easily, and want fast.
Engineering
Build software, firmware, and embedded systems with compliant documentation ready to support FDA and MDR submissions.
Validation and verification (V&V)
Verify performance and validate usability early, so you reduce risk, avoid costly rework, and launch with more confidence.
Manufacturing and maintenance
Enable smooth manufacturing transfer and ongoing maintenance, with fast support for updates, fixes, and vulnerabilities found.
Our design capabilities
Together with our partner, 2s.design, we deliver end-to-end medical device industrial design and GUI expertise. We create world-class enclosures, highly animated interfaces, and marketing visuals that make your device more compelling and easier to sell.
Somco's software expertise
Our roots are in software development for embedded devices, and this expertise still defines Somco today. We build embedded software, connectivity, operating system layers, and GUIs, as well as web, mobile, and desktop applications. We also integrate AI to help medical devices become smarter, more capable, and more valuable to users.
Why Somco Software for medical device design and development?
Regulatory know-how
We create traceable, IEC 62304-compliant documentation that supports smoother audits, reviews, and regulatory submissions.
ISO 13485-certified partner
Work with an ISO 13485-certified, audit-ready team and make your certification process easier, faster, and less risky.
Proven medical portfolio
Benefit from experience across SaMD and physical devices, from spinal surgery robots and infusion pumps to compact wearables.
Quick time to start
Get a fast response, a clear next step, and a team ready to start quickly so your project keeps moving without delay.
Cybersecurity expertise
Cover key FDA-ready cybersecurity needs with support in threat modeling, vulnerability assessment, SBoM, and more.
Industrial design that makes medical devices easier to use - and easier to sell
- Ergonomic product concepts - Designed around real user needs, workflows, and environments.
- Manufacturing-aware design - Concepts aligned with technical constraints and production realities.
- Stronger market perception - Premium visuals and form language that increase product appeal.
Already trusted by
The reviews from selected medical device manufacturers
I always try to recognize as a manager when I’m hiring people, hiring contractors whether there is a match.
You can see that in the dedication, involvement, and engagement of people that we met through a relation with Somco Software.
It told me that this is a group of people I want to work with.
Their friendliness, customer orientation, quality of work,and flexibility were impressive.
Somco Software delivered high-quality UI apps. The client wasvery satisfied with the deliverables and impressed with the partnership. The serviceprovider's team was friendly, flexible, and communicative.
Somco Software has exceptional coding skills, great C++ and Qt knowledge, and an outstanding detail-oriented approach, helping the client solve very simple and deeply complex issues equally.
The team communicates very well, writes clean code, and can scale up very quickly whenever needed.
Cybersecurity - must-havefor all new devices
Cybersecurity is a crucial part of what we do. For Enbio AG, we created cybersecurity documentation from scratch to support FDA submission. This capability is increasingly important, as FDA now requires cybersecurity information for cyber devices submitted through 510(k) and De Novo pathways.
How would next steps look like?
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
We'll address every query and pinpoint the ideal strategy for your project's success.
Fill out the form, and we’ll get back to you shortly.
Lukas Kosiński
Chief Executive Officer