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Rimsys is a comprehensive platform designed to support medical device manufacturers in managing regulatory compliance and data management tasks efficiently. It focuses on providing solutions for Unique Device Identification (UDI) and Post Market Surveillance (PMS), which are crucial for compliance with regulatory standards, particularly in the European Union's EUDAMED system.

The platform offers functionalities that enable seamless data submission and interaction with regulatory databases, ensuring that companies can maintain accurate and up-to-date records. This includes capabilities for machine-to-machine data transfer, allowing for automated and efficient communication with regulatory systems.

Rimsys helps manufacturers organize their regulatory data effectively, ensuring readiness for mandatory submissions and facilitating early data submission to gain advantages in the regulatory process. By leveraging Rimsys, companies can streamline their compliance efforts, reduce the complexity associated with regulatory data management, and focus on core business activities while maintaining high standards of compliance.

Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping medtech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys centralizes all regulatory information, automates submission processes, and provides detailed visibility into product registrations, expirations, relevant standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys is designed around medtech regulations and workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, standards management, and regulatory intelligence in a single, integrated platform. Leading global medtech companies including Johnson & Johnson, Siemens Healthineers, and Omron rely on Rimsys to better manage regulatory projects and resources, get new products to market more quickly, and reduce revenue risk of non-compliance, product recalls, and unexpected expirations.

Website: rimsys.io

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Rimsys

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