Regulated medical software, in practice.

Projects by Silurus Software, from a three week firmware gap analysis to multi-year partnerships on imaging and radiotherapy platforms. Several are separate, long running workstreams (radiotherapy platform, engineering capacity, QA and DevOps, feature development) for one European medical technology manufacturer.

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We do not name clients or products in these case studies. Non-disclosure agreements, our clients' business interests and the confidentiality of their technology do not allow it.

Projects: Regulated medical software projects
Duration: 3 weeks to multi-year
Clients: Manufacturers and a university medical centre in Europe
Standards and regulations: IEC 62304 · ISO 14971 · EU MDR · FDA requirements

Projects

From imaging platforms to device firmware.

Client names are withheld unless the client has agreed to be named. Each case names the sector, the scope and the duration.

RadiotherapyMedical imagingVerification and validationMedical software developmentLaboratory devicesEmbedded software

01 · Radiotherapy · Multi-year

Cloud platform for radiotherapy contouring algorithms

A European manufacturer's cloud platform on which research hospitals run their own contouring algorithms, connected to PACS over DICOM.

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02 · Medical imaging · Multi-year

Engineering capacity for a mission critical imaging platform

Eight engineers inside a European manufacturer's imaging platform teams, IEC 62304, quarterly releases each through full V&V, over several years.

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03 · Verification and validation · Multi-year

QA and DevOps for a regulated software portfolio

Ten specialists running nightly regression and signed builds inside a European manufacturer's release process, over several years.

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04 · Medical software development · Multi-year

IEC 62304 feature development in a large .NET codebase

Senior developers inside a European manufacturer's lifecycle, QMS and review workflow, over several years.

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05 · Laboratory devices · 3 months

Lab device refactoring and IEC 62304 documentation

Desktop application and firmware of a Dutch university medical centre's lab device refactored to be testable, with IEC 62304 documentation, in three months.

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06 · Embedded software · 3 weeks

IEC 62304 gap analysis of safety-critical surgical device firmware

Two people reviewed a safety-critical surgical device's firmware, documents and process against IEC 62304, FDA and MDR in three weeks. The remediation was then contracted to Silurus Software.

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07 · Embedded software · Several months

Remediation of safety-critical surgical device firmware

Defects fixed in four verified phases, a reproducible CI build and three new device features, with the IEC 62304 documents kept in step with every change.

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