Case Study: Mediso Medical Imaging Systems reduces submission time with Cognition Corporation’s compliance platform

Mediso Reduces Time to Submission with Cognition’s Guided Compliance Platform

Mediso Medical Imaging Systems, Ltd., a developer of complex SPECT/CT/PET and MRI imaging systems, needed a faster and more reliable way to manage shared product-family data and generate accurate regulatory submission deliverables for EU and US medical device requirements. The company wanted to reduce repetitive work across modular products, improve first-pass submission accuracy, and better support future systems engineering and “super project” product development. Cognition Corporation provided the Cognition Cockpit guided compliance platform to help address these needs.

Cognition Corporation implemented Cockpit templates, reusable component libraries, automated workflows, and integrated design-risk-test traceability so Mediso could reuse common data across projects and automatically generate structured submission documents. The results included significant time savings, improved data integrity, faster and more accurate DHF and submission deliverables, reduced manual verification, and higher confidence from Mediso’s Notified Body partner. Mediso also reported that Cognition Corporation enabled them to create accurate, auditable documentation and spend more time on device design rather than paperwork.

Mediso Medical Imaging Systems

Miklos Czeller

R&D Director