Announcing Rimsys 5: comprehensive submission management and regulatory intelligence

By
Brad Ryba
-
May 4, 2022
Announcing Rimsys 5: comprehensive submission management and regulatory intelligence

The Rimsys team is both excited and very proud to introduce Rimsys 5 today. The latest version of Rimsys includes a comprehensive regulatory submission module and provides real-time, global regulatory intelligence through a partnership with Clarivate Cortellis. Additional new features include an updated and highly-flexible product hierarchy and the ability to link product, performance, and safety data across the organization through standardized integrations with PLM, eQMS, and ERP systems.

Many of these new features and capabilities were driven by input from our customers.  In addition to the big changes, we’ve also overhauled the user experience, making the entire platform more usable and intuitive.

Medical device UDI software

Rimsys 5 brings a unique approach to regulatory submissions.  The platform now provides regulatory affairs teams with the ability to manage submission projects, collect documents and information, and directly author submission content in a single interface. In addition, customers have full access to their submissions archive without any additional cost. We believe this will lead to significant improvements in productivity for regulatory teams.

What we are most proud of is that only 3 years after introducing Rimsys software to the medtech industry, 10 of the top 30 medical device companies worldwide are trusting their critical regulatory processes to our RIM platform. As the global regulatory landscape becomes more and more complex, Regulatory Information Management (RIM) software will become increasingly critical for medical device companies to bring products to market quickly, and  ensure that they stay on the market. 

Rimsys 5 builds on an already established platform of product-centric regulatory tools, including standards management, UDI, expiration monitoring, market-specific sales status tracking, and more. With version 5 of the platform, regulatory teams can now:

  • Access high-quality comprehensive regulatory information. Powered by Clarivate Cortellis, Rimsys 5 provides access to over 200,000 regulatory documents, updated daily.
  • Build content plans based on government templates. Users have access to fully customizable submission templates for common market applications, including FDA 510(k), STED, NMPA, and PMDA.
  • Collaboratively author submission content. Rimsys allows regulatory affairs teams and other collaborators the ability to work together to create structured submission content within the Rimsys application - without having to jump between outside documents and spreadsheets.
  • Manage submission projects, approvals, and health authority communication. Submission features are wrapped in full project management capabilities, allowing regulatory teams to assign tasks, manage approvals, and track communications with internal teams, partners, and health authorities.
  • Link product, performance, and safety data across the organization. Rimsys 5 provides open integration with PLM, eQMS, and ERP systems allowing regulatory affairs teams to directly pull design history, testing, and quality control documents into regulatory submissions without duplication. Automated alerts let teams know when source documents have been updated.
  • Auto-generate complete regulatory submissions. Rimsys 5 provides automated publishing features that consolidate documents into submission packages in the correct PDF format, creates appendices for file attachments, and renders submissions ready for delivery to health authorities.

All of these features combine to provide a full record of submission history directly linked to individual products, countries, and registrations - giving regulatory teams the tools they need to fully administer, track, and generate regulatory information for every product in every market.

Learn more about the new release at our Rimsys 5 overview webinar on May 18th.

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