Qualio Design Controls is used by medical device companies to structure, strengthen and centralize their product development and quality activities.
This article is written for medical device customers who will use Design Controls for documenting design elements, not a third-party integration (JIRA, Azure DevOps, etc.), and are ready to get started!
Want to learn more about Design Controls first? Get an overview here or take a tour here, or jump to a section in this article:
Permissions and Access
Design Controls is available to all customers on Starter, Growth, and Plus plans for no additional fee. If you are not on one of these plans, or have questions about your current plan, please consult with your Customer Success Manager.
Design Controls must be enabled by customer request via the in-app chat. We recommend enabling the feature first in your sandbox, validating the feature, then enabling and launching in your production environment.
Design Controls can be enabled for all users or a select group of users in any role. Access to the Design Controls tab will give access to the entire suite of Design Control features, including configuration settings. The only discrete permission is the ability to approve changes, which is reserved only for Quality users. Therefore, it is recommended to enable the feature judiciously. Once again, we recommend enabling Design Controls in your sandbox first.
Note: if a user with access to Design Controls changes from one user role to another (ex: Normal to Quality) the Design Controls tab will need to be re-enabled.
Design Controls Validation
Qualio does extensive testing of its software utilizing automated testing tools and we use Design Controls internally for traceability from user needs, to functions, to testing. Then we make those resources available to customers to support their software validation efforts. This validation strategy aligns with the FDA's and other regulatory agencies' "Least Burdensome Approach". Learn more about this new validation approach here.
Click the button below to access and download the Design Controls Feature Validation Pack. Customers can perform additional unscripted testing as needed to fulfill their organization’s validation protocols.
Configure Products, Requirements, Test Cases and Risk
Once access has been granted, and validation is complete, you can now add your first Product. Browse to the Design Controls tab in Qualio, then click the Add Product button.
There are four easy steps for customers to create a product in Design Controls.
Each product has its own unique requirements hierarchy, test case hierarchy and risk management policy. When working with multiple products, your organization may choose to use the same requirements and test case hierarchy and risk management policy, but they must still be configured individually for each product.
Basic Product Information
Give your product a name and select the type of device to be developed. If you need to make changes to the product name or device type down the road, you can edit the product’s information from the Products page.
Click Continue to advance to the next step.
Configure Requirements
Design Controls supports up to three levels of requirements in alignment with the standard V-model for product development. The defaults are listed in the table below, but can be customized as needed.
| Level 1 | Level 2 | Level 3 |
Label | User Need | Design Input | Design Output |
Prefix | UN | DI | DO |
When configuring requirements you can also modify the Statuses of requirements to fit your process. The most common requirement statuses are:
Draft > For Review > For Approval > Effective
To Do > In Progress > Done
Configure Test Cases and Results
Design Controls supports up to three levels of test cases in alignment with the standard models for product development. The defaults are listed in the table below, but can be customized as needed.
| Level 1 | Level 2 | Level 3 |
Label | Validation | Verification | Nul |
Prefix | VAL- | VER- | N/A |
Associated Requirement | User Need (UN) | Design Input (DI) | Design Output (DO) |
Validation ensures the user meets the intended use case in real life scenarios and verification ensures Design outputs meet/satisfy design inputs.
When configuring requirements you can also define the workflow statuses or phases for test cases to follow in your process. An example of test case statuses are:
Summary of Verification: Write up a summary of the verification is step one.
Protocol Drafted: Next step, you need to draft the protocol. In Qualio Docs, create a document from a verification protocol document template
Protocol Approved / Trained-to: Once the protocol draft is complete then you need to approve it and have the performer train to it.
Protocol Performed / Attached: The next step is to perform the protocol. This will be done by the person that trained. They will go through the work instructions, will do the actual testing and will document the results. Whether they document on a spreadsheet that they are going to attach or within the Qualio Documents itself, they will pull all that information together. And, at this point you have a completed protocol with test results.
Report Approved / Attached: Next step is to write a report and link it from the the VER created in design controls
Configure Risk Management Policy
The final step is to configure your product specific Risk Management Policy. You’ll first define the risk record prefix, label and statuses. The most common risk statuses are:
Draft > For Review > Mitigation > Done
Next, you’ll define ISO 14971 assessment risk levels and what risk levels require mitigation. You can add up to 5 levels and modify the labels.
Then, define the related Severity-Probability Matrix. When a risk is logged, severity and probability are the user inputs, and the risk level is the automated output, based on your risk policy. You can choose either three or five levels of severity and probability, then manipulate the individual matrix cells to modify the level of risk. Then based on the risk level, you’ll determine when mitigation needs to occur.
Lastly, you can enable and configure FMEA (Failure Mode Effect Analysis) if you plan to prioritize risks and monitor the effectiveness of risk controls for this product.
To configure, check the box to Enable FMEA, then set (from 1-10) the scale to measure Severity, Occurrence and Detectability and specify the RPN (Risk Priority Number) threshold for requiring risk controls.
Click the Create Product button when you are ready to save your product configuration.
Editing an Existing Product Configuration
You can adjust the configuration of an existing product by clicking the Configure button in the top right of your product display in Design Controls. This allows users to adjust both product requirements and product risks configuration.
Next Steps
Congratulations on creating your first product in Design Controls! You can now begin creating requirements like User Needs, Design Inputs and Design Outputs.