New desks joining a team connected to one code repository

Engineers who join your team and work under your leads.

When the roadmap grows faster than the team, hiring engineers who already work under IEC 62304 takes months. Silurus engineers join your teams, work in your tools, your codebase and your review workflow, inside your ISO 13485 quality management system. Start with one or two engineers and add more as the roadmap needs them.

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Direction: Your leads
Start: 2 to 3 weeks after signature
Process: IEC 62304 · ISO 13485 · your QMS
Location: Budapest · Central European time · English and German

Who joins

Engineers we place in client teams

Application developers

Developers who work in your codebase and your review workflow, under the IEC 62304 lifecycle.

Imaging and DICOM engineers

Engineers with imaging platform experience join for features, performance and field defects.

Medical and dental imaging software →

Embedded engineers

Engineers for bare metal and RTOS targets, used to writing the IEC 62304 records with the code.

Embedded and firmware development →

Test and V&V engineers

Test engineers who write and run the protocols and keep the traceability current.

Verification and validation →

DevOps engineers

Engineers who run the build chain and the release evidence.

Cloud and backend engineers

Engineers who build cloud parts with their SOUP list (software of unknown provenance, meaning third party code used in the device), SBOM (software bill of materials, the list of every software component in the build) and threat model (a structured analysis of how the device could be attacked).

User interface developers

Developers who build interfaces with the usability work IEC 62366-1 asks for.

Regulatory specialists and FDA consultants

Specialists who join your regulatory team for the EU MDR and the FDA.

Regulatory consulting →

In practice

Situations we are asked to solve

Situation

Qt and C++ engineers for a large manufacturer's platform

An engineering partner of a large medical device manufacturer is asked for support on Qt based device software, inside the manufacturer's process.

How we approach it

Our engineers join with Qt 5 or Qt 6, C++ and QML experience, work under the manufacturer's IEC 62304 lifecycle and review workflow, and can start within two to three weeks of signature.

Situation

Firmware capacity for a telemedicine device

A Dutch engineering company develops a telemedicine device with a Linux based monitor, a USB measurement unit and a wireless glucose meter. The prototype code has to be rewritten for the market, and the in house team of four is not enough.

How we approach it

Two embedded engineers join the client's team in C and Python, under its lead engineer, with hardware in the loop testing and the IEC 62304 records for software safety class (A, B or C, by the harm a software failure could cause) B. Maintenance stays with the client.

Situation

Web based 3D imaging for a vascular device

A company developing a thrombectomy system needs developers for its web based software that builds 3D vascular models from CT angiography, to speed up its roadmap.

How we approach it

Engineers with DICOM (the standard for medical images and their exchange), 3D visualisation and web experience join the client's team, with the IEC 62304 records kept in the client's quality system.

Situation

Developers for a contract manufacturer's MedTech client

A product development and contract manufacturing company without its own software team needs Qt and user interface developers to build what it designed for a MedTech client.

How we approach it

Our engineers implement the design under the manufacturer's name and project lead, in the client's process, and the manufacturer keeps the client relationship.

Situation

One or two specialists for a critical phase

A team needs an imaging, embedded, test or DevOps specialist for a release or an audit, without a long hiring process.

How we approach it

Named profiles are proposed for your review, interviews follow your process, and the engineers are onboarded to your procedures before their first change.

How it starts

From the first call to engineers in your team

Week 0

First call

Profiles, standards, tools and the start date are agreed.

Week 1

Profiles

Named engineer profiles for your review, with interviews where your process asks for them.

After signature

Contract and onboarding

NDA, framework agreement and order. The engineers start within two to three weeks of signature, with training on your procedures, and the first changes reviewed by your senior engineers.

Ongoing

In your team

Same tools, cadence and reviews as your own staff, with a monthly statement of the work done.

Ways to work

Which form fits

Team extension fits when

Your own leads direct the work, and the team needs more engineers or a specialist
Engineers should work in your tools, your process and your review workflow

Another form fits when

A workstream needs its own technical lead for years: dedicated team
The result should be delivered against agreed criteria with an end date: project delivery

EU and US

Work that stands up in both markets

European Union

EU MDR

Every change carries its requirement, risk impact and test evidence for the technical documentation, and our regulatory specialists support the file where you need them.

United States

FDA

The same lifecycle records are the basis of the FDA software documentation, at the Basic or Enhanced level the submission needs, and our FDA consultants support it where you need them.

Technologies and standards

What we work with

Technologies and tools

CC++C#.NETPythonJavaKotlinSwiftTypeScriptReactAngularVueQtQMLNordic nRF52ZephyrSTM32FreeRTOSESP32MicroPythonCI/CD

Standards, regulations and practices

IEC 81001-5-1FDA section 524BFDA QMSR (21 CFR 820)SBOMThreat modellingIEC 62304ISO 13485ISO 14971EU MDRFDA

Silurus Software

Silurus Software, founded in 2017, offices in Budapest, Hungary, and Singapore
More than 40 engineers, EU MDR regulatory specialists and FDA consultants
Work inside the client's ISO 13485 quality management system, with the split of tasks written down before the work starts. Where the client has no documented software process yet, we bring IEC 62304 templates for the client to adopt into its own system
Multi-year engineering partner of a European MedTech manufacturer
Founder and CTO Péter Török, in medical technology software since 1999, formerly software development director at Siemens Healthcare (syngo.via) and head of R&D at Mediso Medical Imaging Systems
ISO 9001:2015 (NQA, certificate 171041, valid until March 2027) and ISO/IEC 27001:2022 (NQA, certificate 728872, valid until August 2029)
Awarded AAA, Highest Creditworthiness, by Dun & Bradstreet in 2025
Research partner of ELTE Eötvös Loránd University, Budapest
Industrial partner of the University of Bologna, the University of Pisa, the University of Amsterdam and Masaryk University, Brno, in the EU Horizon Europe project LOGOS from 2027
Female Business Leader of the Year 2025 and The Pioneer Award 2026, awarded to CEO Dr. Linda Szántó

How we work →Quality and standards →Sample deliverables →Case studies →

Related work and pages.

Client names are withheld unless the client has agreed to be named.

Case study

Engineering capacity for a mission critical imaging platform

Eight engineers inside a European manufacturer's imaging platform teams, IEC 62304, quarterly releases each through full V&V, over several years.

Case study

IEC 62304 feature development in a large .NET codebase

Senior developers inside a European manufacturer's lifecycle, QMS and review workflow, over several years.

Dedicated engineering teams Project delivery How we work

FAQ

Frequently asked questions

What is the difference between team extension and a dedicated team?

With team extension, engineers join your teams and your leads direct them. A dedicated team has its own Silurus technical lead and owns a workstream.

Can we start with one engineer?

Yes. You can start with one or two engineers and add more as the roadmap needs.

Can we interview the engineers?

Yes. You receive named profiles, and interviews are part of the proposal where your process asks for them.

Do your engineers work under our QMS?

Yes. They work inside your ISO 13485 quality management system, under your procedures and review workflow.

Which time zone and languages?

Budapest, Central European time, the same working day as Germany, Austria, Switzerland and the Benelux, in English and German.

Do you have Qt engineers?

Yes. Engineers with Qt 5 and Qt 6, C++ and QML experience, including migrations from Qt 5 to Qt 6.

How many engineers can join, and how fast?

From one to a full team, with the first engineers starting within two to three weeks of signature.

Which embedded platforms do your engineers work on?

Nordic nRF52 with Zephyr and the nRF Connect SDK, STM32 with FreeRTOS, ESP32 with MicroPython, and bare metal targets, with drivers, MCUboot and other bootloaders, firmware updates over BLE (DFU (device firmware update)) and signed images.

Can your engineers work in our name towards our client?

Yes. As a subcontractor our engineers work under your delivery management, your NDA and your supplier controls, and your client sees your organisation. Silurus Software is qualified and listed as a supplier in your own quality system, so your auditor sees the full supply chain.

Which cloud platforms do you work with?

We work on Azure, AWS and Google Cloud, whichever the product runs on. The lifecycle is the same on each: the SDKs and libraries go into the SOUP list and the SBOM, the managed cloud services are recorded with their configuration and risk assessment, and the threat model covers the cloud part.

Who approves requirements, risk decisions and releases?

You do, under your QMS. Our engineers write and verify the work, your reviewers and your release authority approve it.

Talk to us

Tell us which engineers you need.

The profiles, the technology and the start date. We reply with named profiles.

Book a 30 minute technical call