Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, 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-centric regulatory solution for the MedTech industry. Rimsys seamlessly integrates with 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 development platform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsys integrates with Arena’s platform by syncing product information so companies can better manage global registrations and selling status at the SKU level. Rimsys has the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitors for documentation changes and alerts users when updates occur with additional reporting based on document location ensuring 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 with Rimsys makes 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.”
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