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

Approval Requests

Standards Status Changes

Insights

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

Rimsys AI

Harness the power of Rimsys AI, a suite of intelligent AI Agents designed exclusively for MedTech

Ready to get started?

Request a free custom demo