Case study · Laboratory devices

From an organically grown lab device to validated use in clinical trials.

In three months Silurus Software refactored the desktop application and embedded firmware of a custom laboratory device used in drug clinical trials, and wrote the IEC 62304 documentation package and the validation plan.

Client: Dutch university medical centre
Duration: 3 months
Team: Dedicated development team
Scope: Desktop application · firmware · IEC 62304

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

A device the trials depended on.

The medical centre had built its own laboratory device for drug clinical trials. Its software, a desktop GUI and embedded firmware, had grown over the years as new needs came up.

For use in regulated drug trials the device had to be formally validated.

That requires documentation, testability and traceability the software did not have.

Clinical trial laboratory

Validated before the next trial.

Challenge

Validation needs software that can be tested.

Without formal validation the device could not be used in regulated drug trials.

Untestable structure

Code had grown without a plan, and tests depended on the physical hardware.

Missing documentation

Requirements and design were not written down in a form a validation could rest on.

No traceability

Nothing linked user needs to verified test results.

Solution

Refactoring first, then the evidence.

Both codebases restructured for testing, then the IEC 62304 file written on top.

We refactored the desktop application and the embedded firmware into a modular architecture, with dependency injection and a simulation mode so tests run without the hardware.

On that structure we wrote the validation plan for the trials and the IEC 62304 documentation: requirements specifications, verification plan, test reports and an end to end traceability matrix.

Scope

What we delivered.

Refactoring

Desktop application and embedded firmware restructured into a modular architecture.

Testability

Dependency injection and a simulation mode, so tests run without the hardware.

Documentation package

Validation plan, requirements specifications, verification plan and test reports.

Traceability

An end to end traceability matrix from user needs to verified test results.

Architecture

Baseline analysis, software architecture document and mid project status reports.

Handover

A structure the client's own team can maintain and extend.

Results

Validated, documented and maintainable in house.

3Months from baseline analysis to validated device

2Codebases refactored, desktop and firmware

IEC 62304Plans, specifications, test reports, traceability

In houseThe client's team maintains and extends it

The device is validated and documented for use in drug clinical trials, with traceability from user needs to verified test results.

IEC 62304ValidationTraceability matrixRefactoringSimulation modeEmbedded firmwareDesktop GUI

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