Skip to Content
Specialized in MedTech software

MedTech software: expertise for development and compliance.

We are your specialized partner for MedTech software development and SaMD compliance.

Book a call
MedtecLIVE
Stuttgart. Meet us on-site. Request a meeting →
Why Silurus

Challenges we solve every day.

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

01 — Talent

Specialist shortages

Experts in DICOM, HL7/FHIR, and IHE are hard to find. We provide them.

02 — Regulation

Regulatory complexity

SaMD compliance (IEC 62304, ISO 13485, MDR/FDA) becomes a productivity drag. We take the load.

03 — Scale

Scaling challenges

Performance, cloud migration, and architecture of existing platforms require real expertise.

Specialized in six core areas
01

Medical imaging

& radiotherapy

02

Healthcare integration

HL7 / FHIR

03

Cloud platforms

Azure, HIPAA / GDPR

04

Regulatory & QA

IEC 62304, ISO 14971

05

SaMD

Software as a Medical Device

06

AI diagnostics

& algorithm development

Some of our clients
How we work

Flexible. Scalable. Tailored to your needs.

Same tools, same standups, same codebase. We integrate into your QMS, not the other way round. Our engineers speak English and German.

Regulatory expertise
IEC 62304 ISO 14971 ISO 13485 FDA 21 CFR Part 820 EU MDR DICOM HL7 / FHIR IHE
Case studies

Proven. Measurable. Real.

Three projects that show how specialized expertise delivers real impact.

Cloud & algorithms

Cloud-based hosting platform for medical algorithms

Leading German MedTech company
30 months · 3 developers + DM

Challenge

Research institutions and clinics lacked the infrastructure for specialized radiotherapy algorithms.

Solution

Cloud-native microservice platform for integration and scaling of contouring algorithms (PACS, DICOM).

Result

Multiple universities deploy algorithms centrally — on-demand, without their own infrastructure.

Long-term partnership

Ongoing development of a medical imaging platform

Major European MedTech corporation
8+ years · senior developers

Challenge

Continuous development of a business-critical platform under IEC 62304 requirements.

Solution

Long-term integration of experienced developers in .NET teams for feature development and risk-based development.

Result

Partnership established for over 8 years with growing scope of responsibility.

QA & DevOps

QA & DevOps for medical device software

Leading German MedTech company
8+ years · 10 specialists

Challenge

Modernization of QA and DevOps processes (EU MDR, FDA) under heavy manual workload.

Solution

Automated CI/CD platform with comprehensive test strategy and full traceability.

Result

Shorter release cycles, daily quality feedback, sustainable compliance.

Let's get started

Talk to a MedTech software expert.

Your next project is ahead of you. Let's figure out how we can best support you.

Book a consultation
Founding team

The people behind Silurus.

Medical engineering, biomedical engineering, software engineering. Deep in the field for over a decade.

Péter Török
Péter Török
Co-founder & CTO
LinkedIn

25+ years of software development. Leadership roles at Siemens Healthcare (syngo.via, Erlangen), evosoft, evopro, and Mediso.

Dr. Linda Szántó
Dr. Linda Szántó
Co-founder & CEO
LinkedIn

Female Business Leader of the Year 2025. The Pioneer Award (2026).

Tamás Fodor
Tamás Fodor
Head of Software Engineering
LinkedIn

10+ years of IEC 62304-compliant development. Degrees in software and biomedical engineering.

Dun & Bradstreet AAA certificate
Official D&B certificate

Silurus holds an AAA rating from Dun & Bradstreet — the highest level, awarded to less than 1% of Hungarian companies.

Silurus Software

Download case studies

Get our complete case studies as PDF.

Silurus Software

Download executive summary

A compact overview for decision-makers as PDF.