Medical Device Essential Principles/GSPR

Monitor and manage global registrations and regulatory applications.

Rimsys is the first and only software platform to manage medical technology essential principles. As more countries adopt essential principles for objective evidence that a product complies, regulatory affairs professionals need to manage these requirements to prevent company bottlenecks, lost time, and risks of audit nonconformities.

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)

Rimsys Principles Module

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.

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Integrates Seamlessly into our other solutions

Medical Device Product Registration

Monitor and manage global registrations and regulatory applications.

Medical Device UDI Software

MedTech UDI software that is fully integrated and automated to a product's registration lifecycle

Medical Device Standards Management

Automatically and proactively monitor and manage global standards.

Medical Device Essential Principles/GSPR

Digitally create, manage, and maintain all Essential Principles.

Medical Device Regulatory Intelligence

Track changing laws, regulations, guidance documents, and relevant news.