The Rimsys RIM Platform
Modern regulatory information management for medtech
A single, cloud platform for end-to-end regulatory process digitization and automation—designed by and for regulatory affairs professionals
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Platform features
Reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners.
SKU-level registration and UDI management
Collect, organize, and manage all regulatory information at the individual product level
Government templates and entrance requirements
Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions
Digital authoring and publishing
Create compliant, submission-ready content, and consolidate PDF packages for electronic and print submissions
GSPR table creation and maintenance
Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes.
Approval workflows
Route approvals, assign tasks, and share notes across teams inside and outside of your organization
Regulations and standards tracking
Get notified of changing standards, laws, regulations, and guidance documents that impact your products
PLM, QMS, ERP, and CRM integration
Seamlessly transfer data and documents across all of your systems, and link selling status directly to your ERP/CRM
Dashboards and reporting
Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status
CASE STUDY
BISCO reduces essential principles & GSPR maintenance by 99%
Discover how Rimsys helped BISCO, a global manufacturer of dental adhesives and cement, automate registration processes and reduce essential principles & GSPR maintenance.
All of your RA processes in one integrated platform
Product registrations
Monitor and manage global product registrations, certificates, and expirations
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Essential principles
Create and maintain essential principles/general safety and performance requirements (GSPR) tables
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