Verification and Validation are the most labour intense, and potentially most time-critical steps in medical device development.

It is all the more important to use the most adequate tools and techniques to reduce overall effort, maximize re-use, avoid delays and gain full visibility into the process.

Design, plan and execute test runs, track your team’s progress and capture results in one place so you always know where things stand.

Use ready-made test case templates to save time or define your own to fit the way you work. Aligned Elements supports your QMS and adapts to your preferred workflows.

By managing Verification and Validation in Aligned Elements, you work more efficiently, make fewer errors, and stay confident in the quality of your documentation.

Generate Test Cases from Requirements and Specifications, author the test step details, or allow our AI draft the Test Case steps for you.  

As a Test Leader, plan your Test Runs ahead and balance the test effort among their team members and analyze the progress in real-time with build it burn-down charts.

Record objective evidence using a rich set of data collection possibilities to align with Medical Device regulations such as FDA QSR 820 and IEC 62304.

Automatically detect incomplete, failed, and unexecuted tests, changes to test cases since last execution, overdue tasks using the built-in inconsistency checks.

Testing often involves multiple team members working in parallel, and delays can appear before you see them coming.

With Aligned Elements, you get real time visibility into who is testing what, what has been completed and what is falling behind.

• Enable efficient, concurrent testing while keeping everyone aligned in one system

• Quickly spot resource bottlenecks with built-progress charts

• Catch issues before they grow using automated checks that flag missing traces, incomplete tests, overdue reviews and more

By monitoring progress as it happens, you can reallocate resources in time and keep your Verification and Validation efforts moving forward, without last minute surprises.

If you already have a Defect Tracking system in place, connect it to Aligned Elements to create new Defect tickets directly from your Test Execution view.

Aligned Elements integrates with a range of systems such as Jira, Azure DevOps, Redmine and GitHub.

Should you prefer to use Aligned Elements own a Defect Tracking system, you are all set. Our Issue System permits the creation, editing, and tracing of defects, applying the same strict version control as applied to other artefacts.

For good reasons, an increasing number of medical device manufacturers rely on automated software tests in their verification process.

Automating tests is an efficient way to conserve human resources and gives you a possibility to re-direct your highly valuable, well-trained, verification personnel to challenge the device in unexpected ways, probe edge cases and concentrate of the probable and improbable scenarios of how human use of the device.  

Leverage your automated software test results in the Aligned traceability by incorporating them as Design Control. This adds additional proof of verification depth and coverage and ultimately improves the quality of your device as well as the comprehensiveness of your Technical Documentation.