RAPS Convergence — Rimsys, the leading provider of Regulatory Information Management (RIM) software for the MedTech industry, today announced a strategic partnership with Clarivate, a global leader in providing trusted information and insights to accelerate the pace of innovation. The new partnership pairs Clarivate Cortellis Regulatory Intelligence™ with the Rimsys RIM Platform, creating a new and unique solution that allows MedTech regulatory affairs professionals to access global regulatory information and harness it directly within automated workflows. The solution enables regulatory affairs professionals to access over 200,000 regulatory documents from more than 80 countries directly in the Rimsys platform and associate them at the individual product level to simplify market submissions and respond rapidly to regulatory changes.
“Today, regulatory affairs professionals spend nearly half their time looking for information, and what they find is often unreliable or poorly translated,” said James Gianoutsos, Founder and President of Rimsys. “Our Advanced Regulatory Intelligence gives them easy access to reliable information and allows them to build powerful automations around it.”
The Rimsys RIM Platform is a cloud-based software solution that is designed explicitly around MedTech regulatory activities and processes. It provides an integrated data hub for all regulatory information and documents and helps regulatory affairs teams streamline and automate critical processes.
Rimsys Advanced Regulatory Intelligence allows MedTech regulatory affairs teams to:
- Identify market entrance requirements and historical product approval data to inform regulatory strategy
- Associate relevant market regulations directly with product registrations and essential principles/GSPR tables
- Automate regulatory product and UDI submissions with digital authoring, approval workflows, and publishing
- Monitor changing laws, regulations, and guidance documents to identify affected products and avoid compliance issues
“We are proud to partner with Rimsys to provide actionable and valuable regulatory information to teams looking to reduce compliance risks and seamlessly bring their products to market,” said Gavin Coney VP, Science Group Channels & Alliances, Clarivate. “Pairing the comprehensive regulatory information of Clarivate Cortellis Regulatory Intelligence with the integrated data hub of the Rimsys Platform will enable users to amalgamate data and insights directly into workflows.”
To learn more about Rimsys Advanced Regulatory Intelligence, visit Rimsys.io.
Rimsys is on a mission to bring regulatory order to the MedTech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, 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 streamlines all regulatory activities including registrations, essential principles, UDI, 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 get new products to market more quickly, and reduce revenue risk of non-compliance, product recalls, and unexpected expirations. For more information, visit www.rimsys.io.