CoComply

RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.

The most powerful, agile approach to risk management. The decisions you make today can help mitigate the risks you may encounter tomorrow. SAI360 is cloud-first software and modern ethics and compliance learning content designed to help your organization effectively navigate risk with a flexible, agile approach. Intelligent solutions, global expertise all in one award-winning platform. Solution configurability, extensible data model with configurable UI/forms, fields, relationships to extend solutions. Process modeling, easily modify or create new processes to automate and streamline risk, compliance, and audit activities. Data visualization and analysis, many out of the box and easy to configure dashboards to visualize and analyze data. Learning and best practice content – preloaded frameworks, control libraries, and regulatory content along with values-based ethics and compliance learning content. System integration – Integration framework with APIs and other protocols.