Silurus Software
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MedTech software partner

MedTech software: expertise for development and compliance

We are your specialised partner, supporting you across every MedTech software and SaMD compliance challenge.

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MedTech DNAno compliance ramp-up
8+ yearstop MedTech manufacturer
Current projectsDE + NL · hospital IT, AI diagnostics
40+ engineersISO 13485 · IEC 62304 · MDR/FDA
AAADun & Bradstreet

What is moving the German MedTech software market right now, and what really matters? Peter Torok, our CTO, discusses exactly these questions in an interview at DMEA 2026 in Berlin, and explains why German companies choose to work with Silurus, among them one of the largest European medical technology groups.

Watch the interview
0+Engineers, Budapest & Singapore
0+Years with EU MedTech manufacturers
2005Founded, Hungarian HQ
​D&B rating, top 1% in Hungary
The challenge

Challenges we solve every day

Medical device manufacturers, healthcare technology companies and R&D teams often face structural problems. We know them all.

Missing specialists

Bottlenecks in specialised developers (for example DICOM, HL7/FHIR, IHE).

Regulatory hurdles

Delays caused by regulatory requirements and compliance (SaMD: IEC 62304, ISO 13485, MDR/FDA).

Scaling limits

Scaling problems in existing platforms (performance, cloud, architecture).

Specialisation in six core areas

Medical imaging and radiotherapy
Healthcare system integration (HL7/FHIR)
Cloud platforms (Azure, HIPAA/GDPR)
Regulatory and QA (IEC 62304, ISO 14971)
SaMD: Software as a Medical Device
AI diagnostics and algorithm development
Our partners

Trusted across MedTech, research, industry and enterprise.

In their words

What partners say after working with us.

IEC 62304 · SaMD
I have been working with Silurus for many years, and I truly value them as a trusted partner. I greatly appreciate their flexibility, responsiveness, and commitment to supporting our needs. Their recruitment process consistently delivers talented professionals who quickly become productive members of our extended team. The consultants working with us demonstrate strong technical expertise, deliver high-quality work, and collaborate exceptionally well across teams.
K+F vezető— Vezető német MedTech-vállalat
Embedded · Product Dev
Silurus delivered a solid solution for one of our projects, with clear communication, reliable output, and on-time delivery. The team was responsive and easy to collaborate with throughout the process.
Nico Drost— CEO, Zign Group
KI-Diagnostik · Forschung
Silurus translated our research vision into clear, technically well-structured content for the European project proposals we led at the University of Bologna, collaborating seamlessly with both our research group and the university administration along the way.
Professor Rita Fioresi— Dipartimento di Farmacia e Biotecnologie · University of Bologna
Engagement models

Flexible. Scalable. Tailored to your requirements.

Embedded systems, clinical applications, regulated development across the lifecycle to IEC 62304. We typically work as an extension of small teams: same tools, same standups, same codebase. We integrate into your QMS, not the other way around. Our developers speak English and German.

A

Integrated engineers

Senior specialists who join your team and work within your development processes and quality systems.

B

Dedicated team

A complete team working exclusively on your project, with the highest commitment and regulatory expertise.

C

Full-cycle development

End-to-end project delivery, from requirements analysis to approval documentation and deployment.

Case Studies

Work that lives inside the clinical workflow.

Detail and references available under NDA. A representative sample.

Case 01 · Cloud & algorithms

Cloud-based medical algorithm hosting platform

Cloud-native microservice platform that hosts, executes, and scales medical image contouring algorithms for university hospitals and research groups, with full DICOM integration to hospital PACS and healthcare-grade data security.

Duration30 months
Team3 dev + 1 DM
ClientGerman MedTech
Case 02 · Long-term partnership

Ongoing development for a medical imaging platform

Feature development, DICOM adoption, security hardening, performance optimisation, diagnostics infrastructure and complex bug resolution on a mission-critical imaging and radiotherapy platform, fully compliant with the client's QMS.

Duration8+ yrs · ongoing
TeamSenior devs
ProcessIEC 62304
Case 03 · QA & DevOps

Medical software QA and DevOps

Full CI/CD platform, release pipelines, DLL/EXE signing, virtualised test environments, overnight regression suites with morning reporting, and multi-layered testing strategies, keeping EU MDR and FDA pace.

Duration8+ yrs · ongoing
Team10 specialists
CoverageEU MDR · FDA
Case 04 · IEC 62304 validation

Medical lab device software & firmware. Refactor and IEC 62304 validation

Custom-built laboratory device used in drug clinical trials. We refactored the desktop application and embedded firmware into a modular, testable architecture with dependency injection and simulation mode, and delivered the full IEC 62304 documentation package and traceability matrix.

Duration3 months
TeamDedicated
ClientNL university med ctr
Case 05 · Regulatory gap analysis

IEC 62304 gap analysis for embedded medical device firmware

Therapeutic device with embedded firmware controlling safety-critical hardware. Review of all software documentation (SRS, SyRS, SDS, architecture) against IEC 62304, static firmware review against FDA and MDR expectations, and identification of safety-relevant control logic errors.

Duration3 weeks
TeamSenior embedded C + PM
ClientPolish MedTech
The team

The people behind Silurus.

Péter Török, MBA
Co-founder & CTO
peter.torok@silurus-software.com

Started as a software developer in 1999 and moved into leadership quickly, with team lead, project manager and head of healthcare roles at evosoft, then software development director at Siemens Healthcare for the syngo.via imaging platform in Erlangen.

Back in Budapest he shaped software strategy as director at evopro Holding, then led R&D teams at Mediso Medical Imaging Systems with agile methodologies. Known for strategic thinking and project efficiency, on deep C++ · C# · .NET roots.

Dr. Linda Szántó
Co-founder & CEO
linda.szanto.dr@silurus-software.com

Co-founder and CEO. As a strategic leader she owns sales, marketing, recruitment and HR, drives international expansion, and leads the digitalisation of the company's operations, building long-term, trust-based partnerships in English and German.

Degrees in law and the humanities. Earlier at an international law firm, the national data protection authority, and in IT project management. Advisory coordinator at ELTE Faculty of Informatics on digital transformation. Female Business Leader of the Year 2025 and The Pioneer Award 2026.

Tamás Fodor
Head of Software Engineering
tamas.fodor@silurus-software.com

Over a decade building software for healthcare under IEC 62304. Degrees in software and biomedical engineering from BME and Semmelweis, where he researched speech-based depression detection using data science and acoustic-phonetic analysis.

Contributed to a major medical imaging platform for a global MedTech company in an FDA-regulated environment, then seven years in radiotherapy software from developer to technical lead. PACS, DICOM, HL7 and DevOps, including AI-driven CT image processing on cloud platforms. Today his scope spans engineering leadership and business development.

Contact

Get in touch.

Whether you are interested in a partnership, want to discuss a concrete MedTech software project or simply want to learn more about how we work, book a meeting with our management directly or write to us.

Book a meeting
hello@silurus-software.com