Services · Consulting

Consulting & project management.

Our consultants are experienced business leaders, developers and technical leads who have delivered large-scale medical software in FDA and MDR-regulated environments. Practical expertise and regulatory knowledge.

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2000 Founded

0+ Team members

0+ Years of leadership exp.

AAA Dun & Bradstreet rating

Why Silurus

Builders who consult.

Unlike traditional advisory firms, our team has hands-on experience shipping regulated medical software.

Engineering-first mindset

Our consultants have written production code for FDA-cleared and CE-marked devices. Advice grounded in real delivery.

Regulatory + technical fluency

We bridge the gap between your development team and regulatory requirements, so compliance does not become a bottleneck.

Budapest & Singapore

With offices in Europe and Asia, we support international market entry and time-zone coverage for global teams.

How we work

From first call to measurable results.

Discovery call

We learn about your product, regulatory context and challenges. Free, no commitment.

Assessment

Gap analysis of your current processes, architecture and compliance posture.

Roadmap

An actionable plan with priorities, milestones and clear ownership for each workstream.

Execution & support

Hands-on implementation support, reviews and ongoing advisory as you scale.

Our expertise

Where consulting makes the difference.

Regulatory strategy & compliance

FDA 21 CFR Part 820 and EU MDR 2017/745 guidance
Risk management (ISO 14971), usability (IEC 62366)
Cybersecurity (IEC 62443), HIPAA and GDPR compliance
Regulatory documentation and submission packages

SDLC optimization

QMS and development process integration
Automated testing pipelines (CI/CD) with traceability
IEC 62304 compliant development workflows
Quality assurance standards and documentation

Product & technology strategy

Software architecture evaluation for scalability
Cloud-native infrastructure for SaMD and imaging
Legacy modernization and API standardization
AI/ML implementation for diagnostics and CDSS

Market & commercial strategy

International market entry (Europe and Southeast Asia)
Go-to-market plans and product launch strategy
Post-launch scaling with clinical insights
Strategic planning for new software products

Team & organizational development

Agile coaching for self-organizing teams
Leadership development and shadow coaching
Cross-functional collaboration frameworks
Mentoring for technical and product leads

Specialized advisory

Medical device interoperability (DICOM/PACS, HL7/FHIR)
Clinical workflow optimization
HIS / RIS / OIS integration
Risk management and cybersecurity guidance

Project management

Delivery on a regulatory clock.

Project management is half the work in regulated software, the part that decides whether the evidence trail closes on time and whether milestones survive contact with audit. We run programmes end to end, embed Project Managers (PMs) and Technical Project Managers (TPMs) into client teams, and step in on projects that are slipping or under regulatory pressure.

End-to-end programme delivery

Multi-year, multi-team medical software programmes from architecture to launch. We own milestones, dependencies and the regulatory clock alongside engineering, and we hand back a defensible design history file on the way through.

Embedded Project & Technical Project Managers

A senior PM or TPM dropped into your existing team, working to your tools and your cadence. Visible progress within weeks, not quarters. Fractional or full-time, with handover documented so the role can come home cleanly.

Recovery & triage

When a regulated project is slipping, blocked, or under audit pressure, we step in to stabilise scope, replan against constraints, and bring it back to a delivery path that holds. Done quietly and with the team in place.

Talk to us

Start with a free discovery call.

Tell us about your product and where you want to take it. We will tell you honestly how we can help.

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