Case study · Embedded software

A three week IEC 62304 gap analysis of safety-critical surgical device firmware.

Silurus Software reviewed the documentation and the firmware of a safety-critical surgical device against IEC 62304, FDA and MDR expectations and delivered a prioritised gap analysis report.

Client: Central European medical technology company
Duration: 3 weeks
Team: Senior embedded C developer, project manager
Scope: SRS · SyRS · SDS · firmware · process

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

Firmware written by one developer.

The device's firmware controls safety critical hardware. It had been written and maintained by a single developer.

Over time the code, its workarounds and the design documents had drifted apart.

Before the product could move through the regulatory process, the company needed an independent and systematic picture of where the software stood.

Safety critical firmware

Where the documents and the code disagree.

Challenge

Find the gaps before the submission.

Compliance gaps, undocumented workarounds and discrepancies between design documents and implementation had to be found, categorised and prioritised in a few weeks.

Documents

SRS, SyRS, SDS and architecture design checked for completeness and consistency.

Code

The firmware reviewed across all components against the documented design.

Process

The software process assessed against IEC 62304, FDA and MDR expectations.

Solution

Documents, code and process, reviewed together.

Three inputs, one review, a prioritised report.

A senior embedded C developer and a project manager ran the review in three weeks.

The findings were categorised and prioritised, from safety relevant control logic errors to documentation gaps, with remediation recommendations for each.

Scope

What the review covered.

Document review

SRS, SyRS, SDS and architecture design against the IEC 62304 lifecycle.

Code review

Static review of the firmware across all components, against the documented design.

Process assessment

The software process against IEC 62304, FDA and MDR expectations.

Critical defects

Safety relevant control logic errors, protocol discrepancies, unresolved fault conditions.

Report

Categorised findings, priorities and remediation recommendations.

Next phase

The basis for the development plan and the submission timeline.

Results

A prioritised basis for the next phase.

3Weeks from kickoff to the gap analysis report

2People, senior embedded C developer and PM

RemediationContracted to Silurus Software after the analysis

The client received a prioritised picture of the gaps between its documentation and its code, assessed against regulatory expectations. The report became the basis for the next development phase and the submission timeline.

The client then contracted Silurus Software for the remediation work.

IEC 62304FDAEU MDREmbedded CStatic reviewSRSSDSGap analysis

More work

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