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Services · Technical consulting and project management

Technical leadership for regulated medical software.

Medical software programmes run for years, across several teams, under audit and submission dates. The consultants of Silurus Software are senior engineers, technical leads and project managers who are experienced in delivering medical software under the EU MDR and the FDA. They review architectures and roadmaps, step in as interim technical leaders, run projects and bring slipping ones back on track.

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Consultants
Senior engineers, leads, PMs
Process
IEC 62304 · ISO 13485 · agile
Route
EU MDR · FDA
Languages
English · German
What we cover

Where consulting and project management help

01

Architecture review

A senior engineer reviews the architecture and the roadmap and gives a written assessment with priorities.

02

Interim technical leadership

An experienced leader covers the role for a defined period and hands it over in a documented way.

03

Project and programme management

Our project managers plan milestones, dependencies and the regulatory timeline together with engineering.

Project delivery →
04

Project managers in your team

A PM or TPM joins your team, works in your tools and cadence, part time or full time.

Team extension →
05

Recovery of projects under pressure

We stabilise the scope, replan against the constraints and bring the project back to a delivery path, with the team in place.

08

Teams and leads

Agile coaching, mentoring for technical and product leads, and collaboration across teams.

In practice

Situations we are asked to solve

Situation

A project under pressure before an audit

A regulated software project is slipping, and an audit or a submission date is at risk.

How we approach it

A senior project manager and a technical lead review the scope, the plan and the evidence, write a recovery plan with priorities and owners, and lead the team back to a delivery path, with the team in place.

Situation

A long running product that needs technical direction

A product has been on the market for years, the original architects have left and the roadmap needs decisions.

How we approach it

An architecture review gives a written assessment of the current system, the risks and the options, and an interim technical leader can carry the decisions until the role is filled.

Situation

A C++ and Qt codebase from a departing supplier

The supplier of a medical desktop product written in C++ and Qt ends the contract, and the product has to stay in maintenance.

How we approach it

Silurus Software plans the handover with you, agrees with you and the outgoing supplier how the code, the build and the access are handed over, and secures them in the first week after the first engineers start, which is two to three weeks after signature, runs handover sessions while the supplier is available and reviews the code and the file with an IEC 62304 gap analysis (a review of what is missing against the standard) that includes the Qt licence and the SOUP list (software of unknown provenance, meaning third party code, or legacy code without adequate development records). Our C++ and Qt engineers take over maintenance and prepare the next release, as a project delivery or team extension engagement. The split between advice, development, verification and approval is written down before the work starts, inside your ISO 13485 QMS, and your named roles approve the documents.

Situation

Code that nobody fully understands

A product was built quickly, partly with AI coding tools, and the team cannot say what the code does or how it will pass an audit.

How we approach it

The technical lead records what the system does, sets up tests that pin the current behaviour, which show what the code does and not that it is correct, and writes a plan that derives the requirements from the intended use and the risk analysis and brings the code under IEC 62304. The results are a code assessment report, a keep or rewrite decision for each module and a test baseline, and the follow up work runs as our service for AI coding tools in regulated development.

How it runs

From the first call to results

Step 1

First call

The product, the situation and the question, free of charge.

Step 2

Assessment

Processes, architecture and plans reviewed, with interviews where needed.

Step 3

Plan

Priorities, milestones and owners for each workstream, in writing.

Step 4

Execution

Reviews, decisions and leadership while your team carries out the plan.

Ways to work

Consulting, a project or a team

Consulting fits when

  • A decision, a review or a plan is needed, and your team does the work
  • A leadership role has to be covered for a defined period

Another form fits when

  • The result should be delivered by one team against agreed criteria: project delivery
  • Engineers should join your own teams under your leads: team extension
EU and US

Advice for both markets

European Union

EU MDR

Plans and decisions made with the EU MDR file in mind, including the qualification and classification of the software under MDR Annex VIII and MDCG 2019-11 (guidance from the EU Medical Device Coordination Group), with our regulatory specialists where needed.

United States

FDA

The FDA submission and quality system requirements built into the plan, with our FDA consultants. You keep the submission and the release decision.

Technologies and standards

What we work with

Technologies and tools

Azure DevOpsGitHub ActionsGitLab CIJenkinsSonarQubeDockerKubernetesC++QtC#.NETPythonCI/CD

Standards, regulations and practices

FDA QMSR (21 CFR 820)IEC 62304ISO 13485ISO 14971AgileScrumEU 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

Related work and pages.

IEC 62304 gap analysisRegulatory consulting, EU MDR and FDAProject deliveryTeam extensionLegacy modernisation and takeoverAI coding tools in regulated developmentHow we work
FAQ

Frequently asked questions

01

Who are your consultants?

Silurus Software senior engineers, technical leads and project managers who have built and delivered regulated medical software. Our Founder and CTO, Péter Török, has worked in medical technology software since 1999.

02

Can you cover a CTO or head of engineering role for a period?

Yes. An experienced leader covers the role for a defined period, with a documented handover.

03

Can you take over a project that is slipping?

Yes. We review the scope and the constraints, replan and lead the project back to a delivery path.

04

Do you also give regulatory advice?

Yes, through our regulatory specialists and FDA consultants on the regulatory consulting service.

05

How does it start?

With a free call. The assessment after it is quoted individually and agreed in writing.

06

What does an architecture review deliver?

A written report on the current architecture, its risks and the options for the next product generation, with a recommendation and the effort for each step.

07

Can you take over a codebase from a departing supplier?

Yes. Together with our legacy modernisation team we plan the handover, take over code and build, and keep the product in maintenance.

08

How does a takeover from a departing supplier run?

We secure the code, the build environment and access to the outgoing supplier in the first week after the team starts, run handover sessions while the supplier is available, make the build reproducible and review the code and the file with an IEC 62304 gap analysis. The first engineers start within two to three weeks of signature, and the team then takes over maintenance and the next release.

09

Which documents does a consulting engagement deliver?

Depending on the engagement: an architecture review report with risks, options and effort, a recovery plan with priorities, owners and milestones, a project plan with the regulatory timeline, and a documented handover when an interim role ends.

Talk to us

Tell us about the project.

The product, the situation and what should change. Write a few lines, or book a free call.

Book a 30 minute technical call
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