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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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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.
100 S. Commons, Suite 102
Pittsburgh, PA 15212
Phone: (855) 846-7269
Founder & President, Rimsys Inc.