Medical device makers call us when an audit or a submission is close, when a product needs engineers who know the medical software standard IEC 62304, or when AI has to work inside a device or a hospital. You get the software and the software documentation for your technical file or your FDA submission, which you file.
The code works, the documentation required for certification or FDA clearance is behind, and an audit or a submission is close. We start from the code and the documents that exist.
The missing IEC 62304 lifecycle documentation, written after the fact on the basis of a gap analysis.
Retrospective IEC 62304 documentationA gap analysis against IEC 62304 in three weeks. You receive a written report and a remediation plan.
IEC 62304 gap analysisThe code becomes testable and traceable again under IEC 62304, and development continues with our team.
Legacy modernisation and takeoverNew device software needs engineers who work under IEC 62304 from the first line of code, inside the manufacturer's own procedures.
Our engineers build it under IEC 62304. We work inside your quality system, or set up the documented process with you if you do not have one yet.
Complete device software developmentBoard bring-up, drivers and the real-time core, developed under the same IEC 62304 lifecycle as the application and cloud software around the device.
Embedded and firmware developmentIEC 62304 verification and ISO 14971 risk files for the technical documentation.
Verification and validationOur engineers join your team under IEC 62304 and use your tools and procedures.
Team extensionAn AI model in a device falls under the same regulation as any other device software. We work for the manufacturer that builds it and for the hospital that buys it.
We build the regulated product around the model under IEC 62304 and ISO 14971, with PACS integration and model change control.
AI model to medical deviceAdvice on which product to buy, and its integration through HL7, FHIR and DICOM.
Clinical AI selection and integrationAI coding tools used inside an IEC 62304 process. Code they have already written is reviewed and brought under control.
AI coding tools in regulated development
C++, C#, .NET and Python teams for imaging, radiotherapy and embedded devices. They take on a defined work package or stay with a product for years.
Gap analyses, retrospective IEC 62304 files, verification and ISO 14971 risk files, written to the manufacturer's templates for the notified body or the FDA.
A working model becomes a medical device, hospitals get advice before they buy clinical AI, and AI coding tools are brought under IEC 62304.
Booking, documentation, reports and moving data between systems take hours of every shift. When software and AI handle the manual steps, doctors and nurses spend that time with patients, and the clinic delivers better care with the staff it has.
We start by sitting with your teams and looking at how the work runs today. We do not sell any AI products or clinical systems, so you get independent expert advice.
A readiness assessment and a shortlist with the questions to ask each supplier, then a local validation in silent mode with a report your quality department can file, and the deployer duties under EU AI Act Article 26.
ImplementationOnline booking, intake forms and draft documents a clinician signs off, introduced one department at a time, with four weeks of hypercare after go live.
IntegrationHIS, PACS, RIS and LIS connected over HL7 v2, FHIR and DICOM, tested against the failure cases, with a runbook for your IT team.
Custom softwareWorklists, dashboards and interface layers for your sites, built and documented under IEC 62304 where they count as a medical device.
Every provider project starts with one separately contracted step with a written result, so you can judge the work before you commit to more.
Talk to our management
Eight engineers inside a European manufacturer's teams, IEC 62304, quarterly releases.
Documents, code and process reviewed against IEC 62304, FDA and MDR in three weeks, then the remediation.
Research hospitals run their own contouring algorithms in the cloud, connected to PACS over DICOM.
Ten specialists run nightly regression and signed builds under EU MDR and FDA.
Senior developers inside a European manufacturer's lifecycle, QMS and review workflow.
Desktop application and firmware made testable, and the full IEC 62304 package, in three months.
An audit, a submission, an MDR transition or a supplier change is coming, and nobody can say how complete the software file is. A gap found now becomes planned work. One found by the notified body or the FDA delays certification or clearance.
In three weeks a senior engineer who knows your device's technology and a regulatory specialist review the documents, the source code and the process of one software system against IEC 62304, ISO 14971 and your EU MDR or FDA route.
It is a small first order with a defined scope. The report is yours, and the remediation is a separate decision: your own team, Silurus Software, or both.
Device makers and healthcare providers face different problems.
More engineers for your imaging platform, inside your release process under IEC 62304.
Engineers for treatment planning and contouring software, under IEC 62304 and IEC 62083.
Older products modernised, with each change documented for the notified body and the IEC 62304 file kept current.
Apps and platforms that now count as medical devices, with the documentation for EU MDR and DiGA.
Apps and wearables that move from wellness and fitness to a medical claim, with the EU MDR file it then needs.
Biomarker reports and risk scores that move towards a diagnostic claim, which can bring them under the IVDR.
Software for your first device, with the software documentation for the EU MDR technical file and an FDA 510(k) or De Novo submission.
Software for the devices you build for clients, with firmware, testing and IEC 62304 documentation.
Software for regulated pharma processes, validated and documented for GxP inspections (GAMP 5, EU GMP Annex 11, 21 CFR Part 11).
An industrial software partner for research devices and EU projects, built with the IEC 62304 records they need to become products.
Less paperwork from booking to discharge, connected to the hospital information system (HIS) and national e-health services.
Online booking across specialties and sites, with referrals and results in the record before the visit (FHIR, HL7).
Faster reports and well prepared patients, with PACS, RIS and AI tools connected.
Less manual work between planning steps, and AI contouring tested retrospectively on your own patient data (DICOM RT).
Every sample tracked from order to result, with the LIMS connected and results delivered electronically.
Treatment cycles that run for months, kept in one record with consents, lab results and follow up.
Booking, recall and treatment plans in one place, with CBCT and intraoral scan data connected.
Care notes at the bedside, visit plans, and device readings with alerts that reach the right nurse, checked against the EU MDR before the alerts are built.
Scoped statement of work and milestones, embedded technical lead and PM.
A team of our engineers that works only on your product and keeps the same people. It grows when your plans need more.
Each engineer is selected for the role you need: development, testing, DevOps or regulatory work.
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.
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.
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.
LeoShape, our orthotic design software, is used in the US, and we needed it reviewed from several FDA angles. Silurus’s consultants gave expert, precise answers on verification and validation, risk management, threat modelling and cybersecurity, and built a well structured plan with us. Their engineers also advised on our order management system’s frontend architecture. Answers came fast, and we could reach them anytime. We turned to them with both compliance and technology issues, and they delivered each time.
These are the standards a medical device and its software are audited against. Our regulatory specialists and FDA consultants work with them every day, and we advise manufacturers on their QMS and submission strategy as a service of its own. When we develop, we work inside your ISO 13485 quality management system, so your auditor assesses your quality system, and every record we write follows your templates, for your technical documentation (EU MDR) and your design and development file (FDA). Certificates, standards and the split of responsibilities are on the Quality and standards page.
The MedTech network in Erlangen lists Silurus Software in its partner directory.
medical-valley-emn.dePRIMUS is the association of private healthcare providers in Hungary, with 67 member providers.
primusegyesulet.huResearch partner of the Faculty of Informatics at Eötvös Loránd University in Budapest.
inf.elte.huHorizon Europe project LOGOS, from 2027: University of Bologna, Masaryk University in Brno, University of Amsterdam, University of Pisa and Universidad Carlos III de Madrid.
Awarded AAA, Highest Creditworthiness, by Dun & Bradstreet in 2025.
Dr. Linda Szántó, CEO of Silurus, took part in the ISO 13485:2016 internal auditor training on 10 and 11 March 2026 (SAASCO Medical and NoBoVersum) and passed the exam. Certificate dated 16 March 2026.
Certified management systems. ISO 9001 is valid until 28 March 2027, ISO 27001 until 25 August 2029.
Quality and standardsCompany recognitions for the business activity of Silurus Software, awarded to our CEO, Dr. Linda Szántó.
Silurus Software was founded in January 2017 by Péter Török and Dr. Linda Szántó. Péter brings more than 25 years in medical imaging and radiotherapy software. Today we develop and document regulated software for medical device manufacturers, and help hospitals and clinics bring digital workflows and clinical AI into daily care. Engineers, EU MDR regulatory specialists, FDA consultants and AI specialists work in one team, with offices in Budapest and Singapore. We hold ISO 9001 and ISO 27001 certificates and carry out joint research with the University of Bologna and the ELTE Faculty of Informatics. See the open positions on the Jobs page.
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. Deep C++, C# and .NET roots.
Learn more →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.
Learn more →Over a decade building software for healthcare under IEC 62304. Degrees in software and biomedical engineering from BME and Semmelweis. He is accountable for delivery, keeps the engineering of every project in hand and leads our work on AI.
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.
Learn more →Leads the Singapore office. More than 15 years of international experience in financial services, particularly investment banking, at global banks including Standard Chartered and UBS across Singapore and Switzerland.
Mid-level management roles across strategy, prime brokerage and institutional derivatives sales and trading. INSEAD MBA. Brings cross-region perspective on regulated industries and APAC operations to Silurus.
Learn more →Short answers to what manufacturers ask before a first call. Anything else, send it with your requirements and it is answered in writing.
Send your question Go to our FAQ pagePricing, contracts, NDA, team, location and languages on the FAQ page.With a call, then your requirements, then an assessment or a proposal. On the call we check device type, software safety class, submission route and timeline. You send the requirements and, under NDA, the existing code and documentation. For finished software the next step is a gap analysis. For new development or added capacity it is a written proposal.
Silurus Software does not publish a rate card, because every engagement is priced individually. Defined work packages, such as a gap analysis or a documentation package, are quoted once the scope is clear. Dedicated engineers who join your team are billed on time and materials. The written proposal states the price model and the amount before anything is committed.
Software in and around medical devices: imaging and radiotherapy platforms, embedded firmware, and the desktop, backend and cloud software around them, including Class IIa and IIb devices under EU MDR. The sectors overview lists every sector.
Yes. Two of our case studies started from existing code: a laboratory device refactored and validated in three months, and safety-critical surgical device firmware reviewed in a three week gap analysis. A takeover starts with the gap analysis, so both sides know the state of the code before a remediation is planned.
Silurus Software has more than 40 engineers. Each engagement is staffed to its work. Our longest running engagement has ten specialists working across several functional teams of one manufacturer, over several years.
Our headquarters are in Budapest, Hungary, at Science Park B, and we have an office in Singapore. Budapest is on Central European Time, the same time zone as Germany, Austria and Switzerland.
Tell us what you are building. On the first call you hear whether we are the right partner for it.
Running a hospital, a clinic group or a laboratory? Talk to our management about which processes and clinical AI tools are worth changing first, and what a first step would involve.
Get our complete case studies as PDF.