Case study · Medical software development

Feature development under IEC 62304, in a large .NET platform.

Senior Silurus Software developers have developed features in a European manufacturer's large .NET medical software platform over several years, inside the manufacturer's IEC 62304 lifecycle and QMS.

Client: European medical technology manufacturer
Duration: Multi-year, ongoing
Team: Senior .NET developers
Process: IEC 62304 · client QMS · client review

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

Every change carries its own evidence.

Under IEC 62304 a code change is not finished when it compiles and passes review.

It has to be traced to a requirement, assessed for risk, verified and documented so that the next audit can follow it.

The platform is large, written in .NET and in continuous development. Every feature moves through the same lifecycle, whoever writes it.

Lifecycle

Technical skill alone was not the constraint. The constraint was skill that already works inside IEC 62304.

Challenge

Developers who work natively inside the process.

Finding developers who deliver at a high technical level and also work naturally within a regulated lifecycle was the persistent bottleneck.

Large codebase

A large .NET platform in continuous development, where a change touches code other teams depend on.

Traceable changes

Each change linked from requirement through implementation to verification.

Client process

New developers had to follow the client's procedures, reviews and quality system from the start.

Solution

Features delivered inside the client's lifecycle.

One path for every change: requirement, risk, code, review, verification.

Our developers work as members of the client's .NET teams, under the client's QMS, development procedures and review workflow.

Risk assessment is part of every change, and traceability runs from the requirement to the implementation and its verification.

Scope

What the developers deliver.

Feature development

New functionality in a large .NET codebase under the IEC 62304 software lifecycle.

Risk aware changes

Risk assessment as part of every change.

Traceability

From requirement to implementation and verification for every change.

Client process

Work under the client's QMS, development procedures and review workflow.

Results

A partnership that keeps growing in scope.

Multi-yearContinuous partnership

Wider scopeMore work entrusted to the team over time

Client QMSEvery change under the client's procedures

The client has kept the partnership over several years and has widened the scope of work given to the team over that time.

IEC 62304ISO 14971ISO 13485 client QMS.NETC#Code reviewTraceability

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