Best e-QMS for SaMD and Medical Device Design Control

S-Cube SmartEye is ready for your next audit inspection, before you even know it’s happening

All your audits will be seamlessly managed in one place for your SaMD. From draft to audit readiness. S-Cube SmartEye transforms, streamlines, and connects all documents and files into one easy-to-use platform. We support all your individual users across different departments and global business territories.


Built to meet the highest of industry standards, without notice

How can S-Cube SmartEye work to streamline your SaMD design and development in one seamless platform?

S-Cube SmartEye allows you to access everything you need for Requirement Management, Test Management, Risk Management and E2E Traceability within one interface

Pre-installed with 100s of ready-made SOPs and templates, including QMS, DHF and Technical files, as well as automatic DHF and DMR files generation - S-Cube SmartEye ensures all your documents meet the necessary industry standards and guidelines, helped by our ready-made checklists

Focused on user experience, S-Cube SmartEye is embedded with Microsoft Office, web grids for bi-directional traceability, global navigators and easy-to-use review and approval features – plus admin screens for a seamless onboarding experience

S-Cube SmartEye has been designed to be a one-stop boutique for QARA, for everything from Design Control and Cyber Security, to Clinical Trials and Post-market Surveillance

With an easy-to-use analytics dashboards to measure the progress of different compliance phases within the S-Cube SmartEye interface, you’ll be able to filter your view by user, team or project

S-Cube SmartEye is adaptable for your entire workforce with different access levels, roles and permissions, including: Organisation Admin, Project Admin, Standard Users and External Users

Arrange your free tailored demo of S-Cube SmartEye today, and see for yourself how an enhanced 360 view could benefit your SaMD design and development.

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