A team with its own lead for one part of your product.

You do. The code and the documents we write for you are yours once paid. If the work ends, we hand over the repositories, the documentation and the open items, with a handover session for your team or your next supplier.

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

The first engineers can start within two to three weeks of signature, and the team is built up in steps.

Yes. The team works inside your ISO 13485 quality management system, under your procedures, design controls and review workflow.

Our team engagements run for years. A change in the team is agreed with you before it happens, the incoming engineer goes through the same onboarding on your procedures, and the handover from the outgoing engineer is planned with you.

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

It is sized to the work, built up in steps as the workstream grows, with a Silurus technical lead.

Yes. As a subcontractor the team works under your delivery management, your NDA and your supplier controls, and your organisation is the contact for your client and the work goes out under your name. Silurus Software is qualified as a supplier in your quality system before the work starts. The subcontract is disclosed where your supplier controls, your client's audit or the notified body (the independent organisation that certifies a device under the EU MDR) require it.

Application development in C#, .NET, C++, Qt and Python, embedded C and C++ on RTOS and bare metal, imaging and DICOM (the standard for medical images and their exchange), test automation and DevOps.

Monthly on the effort, in a statement both sides approve. Where the deliverables of a workstream can be defined in advance, the team can also work in work packages with agreed deliverables.

Yes. The team monitors the SOUP list and the SBOM for new vulnerabilities, assesses and patches them under IEC 81001-5-1 and your change control, and plans the move away from components that reach their end of life.

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 (a structured analysis of how the device could be attacked) covers the cloud part.

Yes. In the first week after the team starts, the code, the build environment and the access to the outgoing supplier are secured. Handover sessions run while the supplier is available, the build is made reproducible on our side, and an IEC 62304 gap analysis (a review of what is missing against the standard) shows the state of the code and the file. The gaps found, such as missing requirements, risk records or traceability, are listed with a plan and agreed with you. The team then takes over maintenance and the next release within your change control.

You do, under your design controls. The Silurus technical lead plans and delivers the workstream, your reviewers and your release authority approve it.