Test management

Build and manage your Medical Device Verifications in Aligned Elements, plan and execute Test Runs, track the progress and results of your Test Team.

Use our standard Medical Device Verification and Validation Test Case templates, or customize any number of test types in Aligned Elements as defined by the development process in your QMS.

Perform test case reviews with our integrated review mechanism to minimize the effort for reviewing and releasing Verification and Validation Test Cases and results.

The Verification and Validation Test Case Execution provides a rich set of possibilities to record objective evidence in accordance with Medical Device regulations such as FDA QSR 820 and IEC 62304.

Quality mechanisms optionally prevent testers from editing the tests they are performing and cautiously notifies the user when attempting to modify test cases that have already been executed. 

Test Leaders can plan and balance the test effort among their team members and analyze the progress.

Automatic consistency checks detect incomplete, failed, and unexecuted tests, changes to test cases since last execution, overdue tasks, and much more. 

Let your test team perform concurrent testing and track their results in Aligned Elements professional Medical Device Test Management system.

Follow the progress using the integrated checks and chart capabilities, and let the automatic consistency checks detect missing traces, unexecuted test cases, overdue reviews, and much more to close all gaps.

Aligned Elements is equipped with a Defect Tracking system which permits the creation, editing, and tracing of defects applying the same strict version control as applied to other artefacts.

You can also connect your existing Defect Tracking system, such as Jira, Azure Devops or GitHub with Aligned Element to create and connect to deviation data in these systems, directly from Aligned Elements.