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.
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.
Watch the videos provided in this article to learn all about Design Controls in Qualio.
Design Controls Workflow for Medical Devices
Learn how medical device teams can use Design Controls throughout product development to assemble requirements and testing, track risks, and review & approve changes. (This video demonstrates “native” Design Controls functionality within Qualio and does not require the use of a 3rd party application.)
(Runtime: 48:51 minutes)
Design Control with 3rd Party Apps
Learn how SaMD teams can integrate Qualio with 3rd Party Software Development applications (Jira, Azure DevOps) to track requirements, testing, and risks. Get a big-picture view of the Software Development lifecycle as it relates to Quality.
(Runtime: 64:16 minutes)