Medical devices

Accelerate medical software engineering.
Simplify assessment preparation.

Spend less time preparing software documents and assembling evidence. KlugSpice helps draft requirements, designs and tests, then brings the records together so engineers can review readiness and prepare for software lifecycle assessments.

01 · ENGINEERING AT AI SPEED

Give engineers more time for the software itself.

Prepare requirements, designs and test specifications using your device needs, project rules and existing software knowledge.

  • Draft software requirements with clear acceptance criteria.
  • Prepare architecture and interface descriptions linked to requirements.
  • Draft test specifications and highlight missing test coverage.
  • Identify documents and tests that need review when software changes.
Explore AI for engineering
02 · ASSESSMENT PREPARATION

Make IEC 62304 evidence easier to prepare and review.

Keep software lifecycle records linked to the work, so engineers can find what is missing before the next assessment or review.

  • Review the software documents and evidence your project already has.
  • Follow links from requirements through design, tests and results.
  • Identify missing records and evidence affected by a change.
  • Prepare readiness findings, review reports and improvement actions.
Explore IEC 62304 support

Start with the work you have.

Assess an existing project, or prepare new engineering work and check readiness as you go.

Engineers approve the changes.
Approved work returns to existing tools.

Software engineering and evidence for your project

Explore standards →

Agree the applicable software lifecycle requirements, assessment scope and evidence expectations for your device.

Engineering benefits

More time for engineering.
Less work around the assessment.

Choose one workflow for a pilot. Compare the effort before and after, using the same task scope and quality expectations.

Less time preparing documents

Measure the hours needed to draft and update requirements, designs and tests that engineers approve.

A shorter path to reviewed work

Track how long a task takes from the first draft to approval, with the sources and checks available to reviewers.

Less effort gathering evidence

Compare the time spent finding missing records, checking links and preparing for an assessment.

See how to measure the benefit
Useful answers

Engineering and assessment in practice.

How does KlugSpice support IEC 62304 software work?

KlugSpice helps prepare software requirements, architecture and verification assets, with traceability to source information and results. Teams can identify missing lifecycle records and organise evidence for the software scope and applicable standard edition agreed for the device.

What happens to the evidence when device software changes?

Change analysis identifies connected requirements, design records and tests that may need review. Engineers can update the affected work, define verification and retain the supporting decisions. KlugSpice supports evidence preparation; product approval remains a separate process.

Start with your work

See KlugSpice in action.

Tell us which task takes too much time. See how KlugSpice can help engineers prepare the work and review the result.

Request a trial licenseOne project. One workflow. Clear success criteria.