Rimsys Pricing Overview

Digitally create, monitor, and manage product registrations and certificates. Stay updated on upcoming expirations and renewals with automated alerts.

Project planning and requirements - Manage requirements, content plans, documents, and tasks for new registrations
Global access and collaboration with distributors or other in-country representatives with controlled access to your registration information
Renewal and expiration reminders track global registrations to keep ahead of expirations and other events that impact market status
Export and marketing controls Integrate selling status with ERP and CRM systems to ensure global go-to-market alignment
Bulk actions enable you to route a group of registration records for approval in the same workflow and make changes to multiple records at once
Interactive dashboards provide views and reports for any country to see exactly where your products can be sold and track registration status
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Integrated and automated global UDI management futureproofs your compliance with management designed to scale as global requirements change

Novel Universal UDI® approach reduces administrative burden and errors which stores common UDI attributes and auto-generates country compliant formats for the US, EU, China, Korea, and more
Automatically populate UDI data including expiration date, notified bodies, and classification from product and certificate records
Push UDI information from your PLM, ERP, CRM, and labeling systems to ensure consistency
Support EU MDR/IVDR requirements with category-level BUDI records, a complete EUDAMED data set, and transmission to EUDAMED
Use our UDI template to collect and structure your disparate data
Submit UDI data directly to health authority databases to eliminate manual duplication and submission errors
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Easily organize and manage a digital library of standards and detailed safety and performance documentation for all of your products

Collaborate with your team to determine applicability, apply standards, and maintain your evidence of compliance
Connect to your EDMS (document management system), PLM, and quality systems to directly integrate information into your tables
Search our library of 1.6 millions standards from over 200 organizations to find the ones you want to follow and receive updates on changes
Integrate automated standards management with your essential principles tables, and get notified of changes
MDR, IVDR, and TGA essential principles tables can be easily customized for notified body requirements
Export completed tables and supporting documentation into consolidated PDF documents for simplified submissions
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Enables users to unlock near real-time insights by seamlessly streaming data from Rimsys directly with their business intelligence tools such as file storage sites, databases, or data warehouses.

Integrate regulatory information from Rimsys with your BI tools such as Google Analytics or Snowflake for speedier reporting and decisions
Seamlessly synchronize key Rimsys information such as product updates, registrations, and submissions with your external systems for streamlined data management
Automate your processes with change data capture to avoid manual imports or API polling by publishing data deltas directly to external systems using event-based updates
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Collaboratively and efficiently author, manage, approve, and publish global regulatory submissions

Access market entrance requirements and government-specific templates for over a dozen different countries
Build submission plans using pre-built and fully customizable templates for FDA 510(k), STED, and other common market applications
Collaboratively, create, edit, and share structured submission content without external documents or spreadsheets
Create variables, snippets, forms, and tables for easy and consistent reuse across submissions
Comprehensive project management empowers you to assign tasks, track correspondence with health authorities, and manage approval processes
Experience submission-ready publishing by rendering documents in the correct PDF format with auto-generated TOCs and appendices based on your content plan
Integrates with eQMS systems to streamline the submission process
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