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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Approval RequestsStandards Status ChangesInsights

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
SKU-level registration and UDI management
Collect, organize, and manage all regulatory information at the individual product level
Government templates and entrance requirements
Government templates and entrance requirements
Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions
Digital authoring and publishing
Digital authoring and publishing
Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions
GSPR table creation and maintenance
GSPR table creation and maintenance
Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes
Approval workflows
Approval workflows
Route approvals, assign tasks, and share notes across teams inside and outside of your organization
Regulations and standards tracking
Regulations and standards tracking
Get notified of changing standards, laws, regulations, and guidance documents that impact your products
PLM, QMS, ERP, and CRM integration
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
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
SKU-level registration and UDI management
Collect, organize, and manage all regulatory information at the individual product level
SKU-level registration and UDI management
Government templates and entrance requirements
Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions
Government templates and entrance requirements
Digital authoring and publishing
Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions
Digital authoring and publishing
GSPR table creation and maintenance
Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes
GSPR table creation and maintenance
Approval workflows
Route approvals, assign tasks, and share notes across teams inside and outside of your organization
Approval workflows
Regulations and standards tracking
Get notified of changing standards, laws, regulations, and guidance documents that impact your products
Regulations and standards tracking
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
PLM, QMS, ERP, and CRM integration
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
Dashboards and reporting
SKU-level registration and UDI management
Government templates and entrance requirements
Digital authoring and publishing
GSPR table creation and maintenance
Approval workflows
Regulations and standards tracking
PLM, QMS, ERP, and CRM integration
Dashboards and reporting
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.

BISCO reduces essential principles & GSPR maintenance by 99%

All of your RA processes in one integrated platform

Product registration

Create, monitor, and manage global registrations and regulatory applications

Unique device identification

Manage global UDI information alongside product registrations

Regulatory intelligence

Track relevant laws, regulations, guidance, and news

Essential principles

Create and maintain essential principles/general safety and performance requirements (GSPR) tables

Standards management

Proactively monitor changing global standards

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