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Design Controls
Navigating Design Controls
Navigating Design Controls

Explore the tabs and features of Design Controls

Written by Lydia Olu-Harding
Updated over a week ago

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After clicking the Design Controls tab, you must first select which Product you would like to manage. There is no limit to the number of products that can be added and managed.

Deleting Products should not be taken lightly as they may not be able to be recovered if deleted in error. Editing Products will have no impact on linked requirements and risks.


After selecting a product, you’ll be brought to the Product Dashboard which is a space to view Change Control activities awaiting either review or approval. Anytime a requirement or risk is added or modified, those items will appear on the dashboard and a Review can be initiated.

Open Issues

Product Development activities have many interdependencies not only between requirements but also between Quality and Product Development teams. With everything moving and changing during the product development lifecycle, and lots of cooks in the kitchen, it’s helpful to have a system that checks for gaps automatically.

Use the Open Issues tab as a checklist of known gaps that need to be resolved.

Learn more about Gap Analysis in Design Controls:


Qualio Design Controls help customers manage the design elements of their products. ‘Design elements’ is a catch-all term which refers to multiple levels of requirements and risks generated during the product development lifecycle. Managing these elements without Design Controls can be time consuming, tedious, and prone to human error. But with Design Controls, your design elements will be arranged logically by product, providing a visual traceability between different levels of requirements and testing.

Learn more about Requirements in Design Controls:


Risk management is a key element of Design Controls for medical devices, because customers need a means to log and mitigate risk to keep end consumers safe. Qualio allows you to follow an ISO 14971 compliant method of risk management as well as Failure Mode Effects Analysis (FMEA) that links to any design element as a source or control of risk.

Learn more about Risk Management in Design Controls:


Qualio Documents relevant to either your product or your design process can be tagged with the specific Design Control tag so that they appear under the Documents tab.

NOTE: The Qualio team must create the required tag. Please reach out to your Qualio rep for more information.

Learn more about Documents in Design Controls:


Anytime a requirement or risk is added or modified, the record will be flagged and listed on the product dashboard to catch your attention. You can then initiate a Design Change Control Review (DCC) from the dashboard. In the review you’ll specify which changes to include in the review, approvers, and linked documents.

Learn more about the Review and Approval Workflow:

Exporting the Review Package

Once your review is approved, an option to export a review package will be available.

This review package will include:

  • Risk Management File

  • Requirements Traceability Matrix

  • Change History

  • Individual documents based on your configuration (e.g. Test Plan, User Needs, User Stories, etc.)

If you don’t need to export the entire package, you can download individual documents in the approved DCC in the Review Documents section.

Note: This section is unavailable until the review (DCC) is approved.

Troubleshooting Errors

While working in Design Controls, error symbols and labels are displayed for missing or outdated information.

You can click to expand for any flagged requirement or test case to see the entire error message.

Error Messages and Meanings

Error Message


Missing Links

A child requirement missing

e.g., a User Need has no Design Inputs

Failing Tests

The test case has no passing test result OR has no test result at all


Missing parent requirement

Unmitigated Risk

Based on your policy, a mitigation is required. Learn more about risk here.

Untested Requirement

The Requirement has no associated test case

Outdated Test Result

The Test Case associated with the test result has been more recently updated, so it is recommended the test case be executed again

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