Medical device software development
Develop secure, compliant, and audit-ready software for medical devices. From software architecture and UX design to verification, documentation, and long-term maintenance.
From software concept to certification-ready medical devices
Whether you’re developing a new medical device, transforming a prototype into a commercial product, or modernizing an existing solution, we help you deliver solutions that meet technical, clinical, and regulatory requirements.
Regulatory readiness
Develop software aligned with IEC 62304, ISO 14971, MDR, and FDA requirements using an ISO 13485-compliant development process.
Secure by design
Build cybersecurity into your software architecture from the beginning, not as an afterthought.
Usability engineering
Design intuitive interfaces that improve usability for healthcare professionals and reduce training requirements.
Audit-ready documentation
Receive complete software documentation supporting verification, validation, and regulatory submissions.
Develop medical device software with confidence
Medical device software must do more than function reliably. It must demonstrate safety, support regulatory compliance, protect sensitive data, and be backed by the documentation required for certification.
Our interdisciplinary team combines software engineering, life science expertise, quality management, and regulatory knowledge to help manufacturers develop software ready for regulatory review that remains scalable, maintainable, and easy to use.
Build on a compliant software foundation
- Software architecture aligned with IEC 62304
- Requirements engineering and software design
- Risk management according to ISO 14971
- Verification and validation planning
- Software documentation for CE marking and FDA regulatory submissions
Develop secure, reliable medical device software
- Secure software architecture and cybersecurity by design
- Software testing and verification
- Traceability throughout the software lifecycle
- Integration with medical device hardware
- Interoperability with healthcare systems
- High-performance, maintainable software
Support every stage of your product lifecycle
- New software development
- Transforming prototypes into commercial products
- Modernization of legacy software
- Feature expansion
- Regulatory updates
- Long-term maintenance and support
We develop software in accordance with international medical device standards and regulations
MDR (EU 2017/745)
EU regulation on medical devices
IEC 62304
Medical device software lifecycle processes
ISO 13485
Quality management systems for medical devices
ISO 14971
Risk management for medical devices
FDA QMSR (21 CFR Part 820)
Quality management system regulation
FDA 21 CFR Part 11
Electronic records and electronic signatures
IEC 81001-5-1
Health software and health IT security
IEC 62366-1
Usability engineering for medical devices
MDR (EU 2017/745)
EU regulation on medical devices
IEC 62304
Medical device software lifecycle processes
ISO 13485
Quality management systems for medical devices
ISO 14971
Risk management for medical devices
FDA QMSR (21 CFR Part 820)
Quality management system regulation
FDA 21 CFR Part 11
Electronic records and electronic signatures
IEC 81001-5-1
Health software and health IT security
IEC 62366-1
Usability engineering for medical devices
Our software development process and lifecycle
“The easy-to-use C.WASH software and its intuitive design gave us a competitive advantage over the competitors in the field of plate washers and liquid dispensers. Many of our customers stated that besides the high quality of the instrument their decision to purchase C.WASH has been significantly influenced by the software.”
Julia Steinert, C.WASH Product Owner, Cytena
“It was our pleasure to work with BioSistemika. We really liked working with them in a highly integrated product development process. The challenging project required a steep learning curve for us all and time to adjust. However, with BioSistemika’s team, we were able to find the best compromises to achieve a successful modus operandi and reach the defined goals. In addition, we appreciate their professionality, flexibility, adaptivity to changes of plans, and capability of being very helpful, even in the more difficult moments.”
Maria Ricci, Data Analyst and Development Engineer, Spindiag GmbH
“Biosistemika has proven to be a valued partner in the development of innovative, long term and challenging project. The Biosistemika’s team covered a critical role in the project providing great support during the major technical decisions as well as discussions and suggestions about the best software approaches throughout the project. Frequent meetings and quick discussions during the software development allowed a continuous alignment to the new user needs raised during the project updates.”
Stefano Ceschia, Research and Development Manager, Alifax
“ LifeTaq-Analytics GmbH has been collaborating with BioSistemika for more than two years working closely together on the project to construct and program an automated 3D cell cultivation robot. We were able to enhance the prototype of the robot by introducing BioSistemika’s software. We really appreciate the constructive work and the relaxing atmosphere during the project and look forward to even closer cooperation in the near future.
Thank you for your trust and support in all matters.”
Manfred Taschner, CEO, LifeTaq Analytics GmbH
“Our team was facing challenges with resource allocation while working toward ambitious development goals – this made it difficult to execute on our vision for a modern, intuitive analysis tool for our customers. Partnering with BioSistemika allowed us to overcome these limitations. They helped us develop the analysis software just as we envisioned—complete with a modern feature layout and improved user experience.
What stood out most was how organized, professional, and transparent they were throughout the entire process. Their responsiveness and structured approach made collaboration smooth and efficient. I would highly recommend BioSistemika to any team looking for a trusted development partner, especially when in-house resources are stretched and quality delivery is essential.”
Build software that is ready to scale and certify
The most important decisions in medical device software development are made long before the first line of code is written.
Software architecture, technology selection, cybersecurity strategy, regulatory classification, and system integrations all influence your product’s maintainability, regulatory compliance, and long-term evolution.
Our experts help you establish the right technical foundation from day one, reducing technical debt, minimizing regulatory risks, and avoiding costly redesigns later in the project.
WE HELP YOU DEFINE
Software architecture
aligned with IEC 62304 and regulatory expectations
Technology stack
that supports long-term maintainability and product evolution
Cybersecurity architecture
and secure software design
Device connectivity
and hardware integration
Integration with hospital systems
and healthcare IT (EHR, HIS, and other clinical systems)
Scalability, performance and future product roadmap
built for today’s needs and tomorrow’s growth
Guidance on software safety classification
and development approach
From our blog
How can we help you?
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