Case Study: Mediso Medical Imaging Systems reduces regulatory submission time with Cognition Corporation's Guided Compliance Platform

Mediso Medical Imaging Systems reduces regulatory submission time with Cognition

Mediso Medical Imaging Systems, a developer of complex medical imaging systems, needed a faster and more accurate way to manage product information and generate compliance deliverables for regulatory submissions to its Notified Body. Their challenge was to reduce repetitive work and improve the accuracy of their submissions for Class IIa and IIb medical devices under EU MDR and MDD directives. They turned to Cognition Corporation and its Guided Compliance Platform, the Cognition Cockpit, for a solution.

Cognition implemented its Cockpit platform, which provided off-the-shelf templates and automated workflows to guide the development process. The solution enabled the reuse of component data across product lines and natively integrated risk analysis with design data. This resulted in dramatic time savings, improved data integrity, and faster, more accurate documentation. Mediso's Notified Body partner noted a significant improvement in the accuracy and timeliness of submission deliverables. Cognition's platform allowed Mediso's engineers to spend more time on design and less on documentation.

Mediso Medical Imaging Systems