NEWS: Arena Solutions and Rimsys Announce Partnership to Offer an End-to-End Quality and Product-Centric Regulatory Solution
Foster City, Calif., January 12, 2021 – Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc., a world-leading provider of a holistic Regulatory Information Management (RIM) software platform designed specifically for medical technology (MedTech) companies.
The Arena and Rimsys partnership offers a secure cloud-based, product-centricregulatory solution for the MedTech industry. Rimsysseamlessly integrateswith Arena’s QMS and PLM solutions by pulling product and documentation information directly into Rimsys to create, manage, and maintain marketing applications such as 510(k), Summary Technical Documentation(STED), and Table of Contents (ToCs).
The Arena product developmentplatform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsysintegrateswith Arena’s platform by syncing product informationso companies can better manage global registrations and selling status at the SKU level. Rimsyshas the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitorsfor documentation changes and alerts users when updates occur with additionalreportingbased on document locationensuring a single and accurate source of truth.
“The seamless and deep integration between Rimsys and Arena solutions reduces the day-to-day regulatory management,” said James Gianoutsos, Founder and President of Rimsys. “The administrative burden of compiling marketing applications and the maintenance of product data is completely eliminated, allowing for increased compliance, efficiency, and visibility throughout the organization.”
“Our partnership withRimsysmakes it easier for MedTech companies to address regulatory affairs, product registration, and standards management more effectively,” said George Lewis, VP of Business Development and Strategy for Arena Solutions. “This new integration streamlines regulatory compliance processes by accelerating the notification of updates to critical quality records and documents.”
About Arena Solutions
Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. Built by and for regulatory affairs professionals, Rimsys digitizes, automates, and creates regulatory order to ensure products adhere to changing global regulations. It is the only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software that makes it easy to manage global UDI requirements and navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence.rimsys.io