Questions about working with Silurus.

Silurus Software does not publish a rate card, because every engagement is priced individually. Work packages, such as a gap analysis or a documentation package, are estimated in hours once the scope is clear, and the estimate is agreed in writing. Code and documents we create for you belong to you once they are paid, and on exit we hand over all of it. 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.

Yes. A gap analysis against IEC 62304 ends in a written report, with scope and duration agreed in writing. It shows what the next phase needs before you commit to it. The price is quoted after a first look at the code and the documents. The first step is described on the How we work page.

Yes. We sign your NDA, or send our own, before any source code, specification or risk file is exchanged.

Yes. A manufacturer that qualifies its suppliers under ISO 13485 has its own supplier agreement and statement of work template, and we contract on those. Where none exists, our written proposal states scope, deliverables, team, duration and responsibilities, and the signed proposal becomes the order.

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.

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.

A member of the management team with an engineering background: Péter Török, Founder and CTO, or Tamás Fodor, Head of Software Engineering. The technical questions are answered on that call.

In yours. The device and its quality management system are the manufacturer's responsibility, so the work runs inside your quality management system: your design controls, your software development and risk management procedures, your document control and your release gates. The split of tasks between you and Silurus Software is written down in the supplier agreement. Our engineers write the lifecycle records to your templates, for your technical documentation and your design and development file.

Silurus Software holds ISO 9001:2015 (NQA, certificate 171041, valid until 28 March 2027) and ISO/IEC 27001:2022 (NQA, certificate 728872, valid until 25 August 2029), see the Quality and standards page. The manufacturer's quality management system is the one assessed at audit, and our work is done inside it.

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 in the same time zone as Germany, Austria and Switzerland, summer time included.

English and German with clients. Hungarian is the language of our Budapest office and is available to clients in Hungary.