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Specialized in MedTech software

MedTech software: expertise for development and compliance.

MedTech is our DNA, no onboarding into compliance required.

40+ engineers under ISO 13485, IEC 62304 and MDR/FDA, with 8+ years partnering one of Europe's largest MedTech manufacturers. Focus on hospital IT and AI-driven diagnostics. AAA D&B rated, top 1% in Hungary.

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40+ Engineers · Budapest & Singapore

8+ Years partnering EU MedTech OEMs

2017 Founded · Hungarian HQ

AAA D&B · top 1% in Hungary

What you can count on

Why medical device companies choose Silurus.

Founded in 2017, Silurus Software builds regulation-ready software for healthcare and beyond, from our offices in Budapest and Singapore. More than 40 colleagues focus primarily on medical device software development.

We build systems that meet strict regulatory requirements while adapting to each partner's needs: regulated Class IIa/IIb device software from concept to submission, medical imaging and DICOM pipelines, radiotherapy and treatment planning, embedded firmware for surgical and clinical-trial instruments, and the clinician- and patient-facing apps around them. Our lead experts bring over 20 years of experience, and the company has operated in the medical software market for more than nine years.

UI/UX revamps, refactoring legacy codebases, and the build, test and DevOps work that keeps releases moving at regulatory pace. We work fast, precisely and at high quality, from a quick prototype or tight-deadline refactor and validation to long-term enterprise contracts with continuous delivery.

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Reliability

Medical device programs are multi-year commitments where supplier discontinuity creates regulatory and engineering risk that is hard to recover from. Our client engagements run for years, our team retention is stable, our financials are audited and AAA-rated.

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Quality & ISO compliance

ISO 13485 and IEC 62304 are the operating frame of our engineering. The verification, traceability and design history artefacts we produce are formatted for notified body review, FDA submission and internal QA without rework.

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Deep expertise

Imaging, radiotherapy and clinical integration carry decades of accumulated patterns: DICOM dialects, vendor-specific HL7, radiotherapy planning math, GPU constraints. We bring engineers who have shipped production code in those domains.

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Speed without compromise

Delivery speed in a regulated context is a function of process discipline, not corner-cutting. We compress lead times by carrying the regulatory artefacts in parallel with engineering, so submission and verification cycles do not dictate the schedule.

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Security by design

Connected medical and clinical systems are now in scope for MDR cybersecurity expectations, NIS2 and FDA pre-market cyber guidance. Security is architected into the system from the first design decisions, on top of an ISO 27001 management practice.

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Global reach

Medical device programs increasingly span EU and APAC stakeholders, regulators and clinical partners. Our Budapest and Singapore teams give you continuous coverage in both regions, with English and German as the working languages.

Our partners

Trusted across MedTech, research, industry and enterprise.

In their words

What partners say after working with us.

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

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

A radiologist reviewing multi-planar brain MRI on a DICOM viewer. Representative imaging workflow.

Standards we work to

Standards we build to.

The frameworks our delivery process maps to, from quality management to market access.

ISO 13485Quality management system. The operating frame for every medical device organisation.

IEC 62304Software lifecycle requirements. The default, not a project-end documentation exercise.

ISO 14971Risk management. Hazard analysis, controls and post-market surveillance, running with engineering.

IEC 62366Usability engineering. UI design, formative and summative evaluation, use-error analysis.

IEC 81001-5-1Health software cybersecurity. Threat modelling through to post-market vulnerability management.

DICOM · HL7 · FHIRInteroperability protocols. Production integrations against PACS, EMRs, RIS.

GDPR · HIPAAPrivacy regimes. Data handling and retention designed in from day one.

FDA · EU MDRMarket access. Design controls, technical documentation, post-market obligations for both tracks.

IEC 62304 lifecycle

How we work the standards into the build.

Every left-side activity has a matching verification on the right. Traceability runs across, not bolted on at submission.

Development ↔ Verification

L1 User needs

R1 Validation

L2 Software requirements

R2 System testing

L3 Architecture

R3 Integration testing

L4 Detailed design

R4 Unit verification

Implementation

IEC 62304

What we do

Services.

From regulated device software to the consulting and coaching around it. Each area links through to the detail.

Medical Software Development

Application and platform software for medical devices and clinical systems. Diagnostic imaging, radiotherapy planning, AI-based diagnostics, mobile and wearable software, web platforms, and the operator UI on top of them. Project sizes range from a single feature inside a regulated product to a full standalone application, all built under IEC 62304 and ISO 13485 with the verification and design history records the QMS requires.

IEC 62304ISO 13485DICOM

Embedded Software Development

Firmware and on-device software for medical and industrial instruments. Board bring-up, drivers, the real-time core, control logic, sensor and actuator interfacing, and the on-device UI. Targets include surgical systems, clinical-trial instruments, point-of-care diagnostics and portable monitoring devices, as well as industrial automation and inspection equipment.

C / C++RTOSFirmware

QA, Compliance & Regulatory

Verification, validation, risk management and the regulatory documentation required for medical software, plus the security and compliance work that applies more broadly. ISO 14971 risk files, IEC 62304 design history, ISO 27001 ISMS and NIS2 readiness, and the inputs to MDR technical documentation and FDA pre-market submissions. Delivered as part of an engineering engagement or as a standalone workstream supporting your in-house team.

ISO 14971ISO 27001NIS2

Consulting & Project Management

Technical strategy, software architecture and programme leadership across industries. Engagements range from a short advisory review of an architecture or roadmap, through interim CTO or VP Engineering coverage, to embedded project and product leadership inside the customer organisation. Delivered by senior engineers with shipped products behind them in medical, industrial and enterprise contexts.

StrategyAgileDelivery

Implementation & Integration

On-site implementation and rollout work for clinical and enterprise systems, with a focus on DACH and the EU. Our consultants embed with the customer, take ownership of the implementation cycle, and stay through go-live and the first weeks of operation. Scope covers ERP and WMS rollouts, HL7 and FHIR integration, PACS and clinical systems, EDI work, and the on-site training delivered in German or English where the operator team needs it.

Training & Coaching

Engineering coaching and leadership development for software teams. Topics range from medical-specific work (IEC 62304 process introduction, design control practice, ISO 14971 risk management) to domain-agnostic (architecture reviews, code review and verification habits, technical leadership, working patterns that hold up under audit). Delivered as workshops, embedded coaching, or both.

AgileMentoringLeadership

Engagement models

Three ways to work with us. All of them long-term minded.

A · Project delivery

A fixed-scope team, accountable for an outcome and timeline.

Scoped statement of work and milestones, embedded technical lead and PM.

Defined deliverables and acceptance criteria
Verification artefacts on delivery
Smooth handover or continued support
Aligned with your QMS, or ours

Best forwell-defined modules, replatforming, submissions

B · Dedicated team · Most chosen

A long-running team that learns your product and stays with it.

Two to twelve engineers, ramped to fit. Direct line to senior architects.

Embedded into your tooling and cadence
Continuous improvement, not project hand-offs
Aligned to your QMS, or ours
Stable team membership, year over year

Best formulti-year product lines, regulated roadmaps

C · Staff augmentation

Senior engineers slotted into your team by skill set and seniority.

Hand-picked, never bench-cleared. Imaging, RT, C++, Python, .NET.

Direct integration with your team's process
Notice periods that respect your cycle
Optional fractional architects
Background-checked, NDA-bound

Best forcapacity gaps, deep-skill top-ups

The team

The people behind Silurus.

Silurus was founded in January 2017 as a software engineering partner for the medical technology sector. Today we are 40+ specialists in development, QA, DevOps and regulatory, across Budapest and Singapore. AAA rated by Dun & Bradstreet, top 1% in Hungary.

Péter Török

Péter Török

Co-founder & CTO

25+ years in software. Previously evosoft, Siemens Healthcare, evopro Holding, Mediso Medical Imaging.

Dr. Linda Szántó

Dr. Linda Szántó

Co-founder & CEO

Law and humanities. Background in international law, data protection and IT project management.

Tamás Fodor

Tamás Fodor

Head of Software Engineering

Software and biomedical engineering. Focus on IEC 62304 medical software standards.

András Török

András Török

Head of Singapore Office

INSEAD MBA. 15+ years in international financial services at Standard Chartered and UBS.

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Careers

Join the team.

See open positions

Below is what every colleague gets, regardless of role or seniority.

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Home office & hybrid

Teams typically meet in the office once a week or every other week, with most work done remotely. Comfortable for colleagues outside the city, less time spent commuting.

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Long-term employment

We employ our staff on indefinite contracts. Stability is a feature, not a perk.

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Premium private health insurance

Every employee receives premium private health insurance, with extensive annual screening and high-quality care in case of illness, covered nationwide.

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International work environment

Our teams collaborate continuously in English with American, Swiss, German, and Finnish counterparts.

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Training opportunities

We support professional development with internal and external training. Funded conferences, study groups, and time for the deep papers.

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Silurus Academy

In our academy programme we train young graduates in groups, and upon successful performance, offer them permanent positions.

Get in touch

Start a technical conversation,
not a sales call.

Tell us what you are building. We will tell you whether we are the right partner, honestly, and on the first call.

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