Digitally create, manage, and maintain all Essential Principles, including the EU MDR and IVDR General Safety and
Performance Requirements (GSPR)
- Automatic notifications of changed standards and evidence files
- Bulk updates throughout all records
- Approval workflows and auto-generated PDFs
Includes the EU MDR and IVDR
General Safety and Performance Requirements (GSPR)

How Rimsys Helps with Essential Principles
Compliant with the new EU MDR and IVDR.
Step 1
Create a Product Profile
Define product families and business units, and assign products, part numbers, UDI’s, and more.
Step 2
Create Your Product’s Essential Principles Table
Easily create an interactive, collaborative essential principles table with just a few clicks.
Step 3
Collaborate and Manage
Collaborate with your team to determine applicability, apply standards, and maintain your evidence of compliance.
Step 4
Route and Monitor
Route the essential principles table for approval and connect your EDMS to our software for document integration and routing/approval capabilities.