ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control.
ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction.
Accelerate time to market by better business process integration to plan, execute, and track all global regulatory activities in a single, integrated RIM application, with continuous access to regulatory documents and full support for global regulatory submission requirements to speed-up health authority submission timelines. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.
Reduce risk and stay compliant with the latest regulatory requirements with a built-in Reg Intel that keeps you up-to-date in real-time. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.
Manage the entire regulatory lifecycle in a single platform with intuitive, ease to use user interface, for faster adoption and better ROI. Streamline planning and tracking of interactions, commitments and obligations, as well as document and dossier management, publishing, reporting, and data standards compliance with our alert management system. Integrated reports and charts support management’s overview of critical renewal dates, current ongoing activities, and finalized tasks completed in the last few months.
Add efficiency without losing control by automating manual workflows including intelligent task assignment, submission planning, and performance tracking and increase connectivity for improved efficiency, decreased costs, better coordination and cross-enterprise visibility. Our pre-configured templates help expedite regulatory submission and dossier planning. Automatic notifications help you to inform the assigned users about new tasks or send reminders before due date
Ready to improve your efficiency and lead the regulatory function "better" ?
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