Qualio Design Controls help customers manage the design elements of their medical device 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 outside of 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, and available for easy export keeping companies completely audit-ready at all times.

This article is written for medical device customers who will use the native Design Controls Requirements for product documentation, not a third-party integration (JIRA, Azure DevOps, etc.), and have previously configured products and related policies in Design Controls. This article describes the following:

Create a New Requirement

When a new requirement is created in Design Controls, the pre-configured requirements policy for that specific product will be applied. Because requirement policies can be customized, your terminology (label, prefixes, and statuses) may appear differently than what it displayed in this article.

Navigate to the Requirements tab, then click the New button, then Requirement option.

Fill in the short form using the information below:

Title	Required field Define a short summary title of the requirement Note: a document ID with the defined prefix will appear before the title (ex: UN-1 Pump Durability
Requirement Type	Required field Auto-populates, but can be changed during initial creation. Cannot be changed after saving. Determines the requirement level (1, 2, 3 or 4) which will impact the Related Design Elements that should be linked to this requirement Types are defined by the product’s requirement policy
Component	Allows grouping of design elements under components to model product architecture Supports complex product structures with multiple modules, subsystems, or components Note: Can be created through Resource Library
Category of Design Element	Improves organization and traceability of product requirements, user needs, design inputs/outputs, and test cases. Supports product teams by aligning with standard industry best practices. Note: Can be created through Resource Library
Description	Capture the requirement statement Open text field with no character limit Cannot be templatized NOTE: Currently, no SmartLink or tagging functionality, but regular hyperlinks can be added to link to Qualio Documents or other sites.
Related Design Elements	Link to other requirement documents Requirements can be created without linking to other design elements Multiple design elements can be added
Attachments	Browse for files or drag and drop files to the Attachments area Single file size limit: 500MB Total storage per requirement: 100MB (maximum file size accepted by regulatory bodies) Up to 10 attachments per requirement Attachments are zipped and exported within each Review created

Note: Changing the requirement Type impacts the related Design elements.

The newly created requirement will display on next page after you save it.

It will also display on Requirements tab. This list includes all levels of requirements as configured for your product, e.g. user needs, design inputs, design outputs, etc, with additional context to organize and troubleshoot ahead of reviews. You can also edit and delete your requirement.

Note: You can also filter your Requirements by clicking on Funnel icon:

Managing Categories and Components in Design Controls

Two attributes, Category and Component are now managed centrally in the Resource Library, and can be assigned via drop-down when creating design elements.

Categories for Regulatory Compliance

Categorization helps streamline compliance with regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485 by:

Simplifying audits and inspections through structured design elements.
Improving traceability and organization within reports.

Categorizing Design Elements for Best Practices

Categorization enhances organization and traceability of product requirements, user needs, design inputs/outputs, and test cases.
This approach aligns with standard industry best practices, making it easier for product teams to integrate Design Controls into their workflows.

Components for Managing Complex Product Architectures

Many products consist of multiple modules, subsystems, or components. The ability to group design elements under Components allows teams to:

Model their product architecture within requirements.
Improve visibility and logical grouping of related design elements.

Using Categories and Components in Design Controls

To leverage this new functionality:

Add categories and components in the Resource Library
- Qualio provides pre-defined resources, including Level 1 requirement categories, Level 2 test categories, and components.
Assign categories and components to requirements, tests, and risks
- When creating or editing a requirement, select from the available dropdown options to categorize it correctly.
Display categories and components within Design Controls
- Categories will be visible in UI and exports.
- Components will appear only in the UI, as they are considered internal information.

Editing and Updating Requirements

As product development progresses, you’ll need to modify or update requirements like update title or description, change the status, and connect related design elements. Note that once created, the ID and Requirement Type (level) cannot be modified.

To edit a requirement, browse to the Requirements tab. Browse to the requirement, then use the 3 dot icon on the right side of the requirement to edit.

Deleting Requirements

As product development progresses, you may decide to scrap a requirement. Using the delete option will permit you to remove requirements that no longer apply or perhaps have been made redundant.

To delete a requirement, browse to the Requirements tab. Browse to the requirement, then use the 3 dots icon on the right side of the requirement to delete. You can not undo this action.

You can find deleted requirement in Audit Trail logs.

If a requirement was previously approved, it will appear with the status 'DELETED' when adding requirements to your next review/DCC.

Next Steps

Once a few design requirements have been added, you may be ready to assess and log risks associated with the design requirements or add Test Cases. Use the buttons below to continue learning about Design Controls.

How to Assess Product Risk in Design Controls

Add Test Cases for Design Validation and Verification

Manage Product Requirements in Design Controls