The Challenge

Quality teams and product development teams use different systems to track design requirements, testing and risks. Siloed teams and systems make traceability and compliant releases impossible to manage. Without a single source of truth, Quality Teams spend tremendous amounts of time and effort towards evidencing product development outcomes, or work grinds to a halt, opening teams to risk and hindering innovation.

The Solution

Qualio Design Controls unites your team’s systems in your QMS, making Qualio the single source of truth for all of your product development and quality activities. Design Controls enables end-to-end traceability, ISO 14971 and FMEA risk assessment, allows you to easily identify gaps, and prepare release documentation.

Design Controls is built in harmony with ISO 13485 Clause 7 and CFR 820.30. The platform surfaces quality and safety impacts and produces output documentation in one click, so your product team can focus on building great products, and your quality team can focus on audits and certifications.

Requirements Options

One of the major benefits to using Design Controls is to have all design elements requirements (user need, design input, design output, verification and validation) in your eQMS. Risks can then be logged and associated with related design elements, risk mitigation actions tracked, and release documentation can be easily generated with all approved documentation.

So, how do requirements get added to Design Controls? There are two ways and each method has unique configuration and requirements management instructions. Consider the two options below, along with the suggested customer profile and dependencies to determine which option is the best for your organization. Then click the button for the next suggested article.

  1. Add Requirements directly in Design Controls from the Requirements tab.

    • Ideal for Medical Device products that are early-stage (pre-market).

    • Can be self-implemented with minimal Qualio support, and no 3rd party integration.

    • Reduces software and license costs because everything is contained within Qualio.

  2. Integration with your 3rd Party Product Development system.


If you are interested in Design Controls and have questions, reach out to either our Support team via in-app chat, or your Customer Success Manager. Or, you can continue to browse other articles to learn more about Design Controls:

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