Case study · Medical imaging

Engineering capacity for a mission critical imaging platform.

Over several years Silurus Software engineers have worked inside a European manufacturer's engineering teams on a clinical imaging platform for diagnostics and treatment planning, under IEC 62304.

Client: European MedTech manufacturer
Duration: Multi-year, ongoing
Team: 5 developers, 1 lead DevOps engineer, 2 test engineers
Technology: Azure · Azure DevOps · C# · C++ · Terraform

We do not name the client or the product. Non-disclosure agreements, the client's business interests and the confidentiality of its technology do not allow it.

Context

When software downtime means a patient waits days.

In a hospital, patients are treated in tightly scheduled time windows, sometimes as short as fifteen minutes. If the software falters, the disruption does not last minutes.

It pushes scheduled treatments back by days, and for many of those patients the treatment is critical to their care.

This is the standard the platform is held to. Every change has to be traceable, risk assessed and verified before it reaches a clinical site, under a strict IEC 62304 software lifecycle that runs continuously: new features, evolving DICOM standards, security hardening, performance work and defect investigations from real clinical sites.

Clinical imaging

Treatment windows as short as fifteen minutes.

Challenge

Scaling a regulated team without breaking the chain of evidence.

The client needed to grow engineering capacity fast enough to cover all of this in parallel, without letting quality, traceability or compliance slip.

Capacity

Features, DICOM updates, security, performance and field defects all run at the same time. Internal hiring could not keep pace with the domain knowledge this needs.

Day one standard

New engineers had to work to the same standard as the client's own engineers from the first change, traceable from requirement to release documentation.

Patient safety

The risk was not only slower delivery or audit findings. A single weak link in the process is, above all, a risk to patients.

Solution

An embedded team across the full lifecycle.

Every change carries its evidence, from requirement to the quarterly release.

Over the years, Silurus engineers became an extension of the client's own engineering organisation, working within the same quality system, review processes and regulatory framework.

The team works the V-model end to end. Requirements trace to design, design to code and code to verification, and user needs trace to validation, with nightly builds and regression tests holding the chain together between releases.

Scope

What the team owns.

Idea to proof

Requirements, design, implementation, verification and validation, each change with its evidence.

New capability

Features inside the IEC 62304 platform, including support for new DICOM editions and supplements.

Performance on schedule

Database optimisation and network fault investigation for clinical time windows.

Security built in

Hardening, vulnerability investigation and cybersecurity analysis in the lifecycle.

Verified releases

Nightly builds, regression testing and code coverage that is measured and improved.

Field root cause analysis

High severity issues from clinical sites, and direct customer support.

Predictable rhythm

Quarterly releases, each through the complete verification and validation process.

Audit ready documentation

A standing responsibility for every engineer, to the standard the lifecycle requires.

Results

Long term scalability with full compliance.

Multi-yearPartnership, scope expanding over time

8Engineers across development, DevOps and test

4^/yrReleases, each through full V&V

Audit after auditCleared across years of regulated development

The partnership has let the client expand engineering capacity while keeping the standards regulated medical software requires, with every new engineer trained on the client's procedures before the first change.

Process adherence and output quality are on par with the client's own engineering staff.

IEC 62304ISO 14971ISO 13485 client QMSDICOMEU MDRAzure DevOpsC#C++Terraform

More work

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