“Adoption by half of the top global MedTech manufacturers is a powerful validation that we’re not just a solution, we’re setting the new gold standard for regulatory excellence.”

‍

Pittsburgh, PA - August 7, 2025 - Rimsys, the leading Regulatory Information Management (RIM) software purpose-built for the MedTech industry, today announced a significant milestone: 6 of the world’s top 12 medical device manufacturers now rely on Rimsys to manage and streamline their global regulatory operations.

This milestone further solidifies Rimsys’ position as the trusted partner to the world’s most innovative and quality-focused MedTech companies.

Click here for the full list of the top 12 global MedTech companies.

“Today’s regulatory environment demands more than spreadsheets. Leading manufacturers recognize that regulatory operations are mission-critical, revenue-generating departments and need systems to match that level of importance,” said James Gianoutsos, Founder and CEO of Rimsys.  

Rimsys’ unified, enterprise-grade RIM platform centralizes and automates critical regulatory processes—including market registrations, Unique Device Identification (UDI), essential principles/GSPR, and submissions management—reducing compliance risk and accelerating market access. Specifically tailored to the needs of medical device and diagnostics companies, Rimsys enables seamless collaboration across RA, QA, and commercial teams while delivering the audit-ready transparency global regulators demand.  

“As more organizations embrace regulatory digital transformation, Rimsys is proud to lead the industry forward,” added Gianoutsos. “Adoption by half of the top global MedTech manufacturers is a powerful validation that we’re not just a solution, we’re setting the new gold standard for regulatory excellence.”

To learn more about the Rimsys, please visit www.rimsys.io.

‍

About Rimsys

Rimsys is the leading provider of Regulatory Information Management (RIM) software purpose-built for MedTech manufacturers. The comprehensive platform digitizes and automates regulatory activities, helping MedTech regulatory affairs teams to efficiently achieve regulatory compliance and get products to market faster. Rimsys is designed around MedTech workflows and supports a full breadth of regulatory functions including registrations, submissions, UDI, EUDAMED compliance, essential principles, and standards management in a unified platform. Rimsys is trusted by half of the world’s top 12 MedTech companies to power their global regulatory operations. For more information, visit www.rimsys.io.