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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

Manage regulatory projects and resources more effectively, get new products to market more quickly, and reduce revenue risk of non-compliance issues, product recalls, and unexpected expirations.

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
Smart submission authoring
Smart submission authoring
Streamline regulatory submissions with collaborative authoring, intelligent reusable content, and compliant PDF generation
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
Smart submission authoring
Streamline regulatory submissions with collaborative authoring, intelligent reusable content, and compliant PDF generation
Smart submission authoring
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
Smart submission authoring
GSPR table creation and maintenance
Approval workflows
Regulations and standards tracking
PLM, QMS, ERP, and CRM integration
Dashboards and reporting
CASE STUDY

Omron reduces time spent on regulatory reporting by 98%

Discover how Rimsys helped Omron, a leading global medical device manufacturer of heart monitoring equipment, blood pressure monitors, digital thermometers, and nebulizers, digitize product registrations, eliminate information silos, and streamline reporting across office locations.

Omron reduces time spent on regulatory reporting by 98%

All of your RA processes in one integrated platform

Product registrations

Monitor and manage global product registrations, certificates, and expirations

Submissions

Collaboratively author and assemble 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

Ready to get started?
Request a free custom demo