Digitally create and maintain medical device essential principles

Easily organize and manage detailed safety and performance documentation for all of your products

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Digitally create and maintain medical device essential principles
GSPR regulations are leaving products behind

As more countries adopt essential principles for objective evidence of product compliance, medtech companies are struggling to keep up. Analysts have estimated that up to 50% of products will be withdrawn from the European market as the new general safety and performance requirements (GSPR) of the MDR and IVDR regulations come online.

Rimsys streamlines the creation and management of essential principles tables, allowing you to make bulk updates, automate approval workflows, and receive notifications when standards or evidence change.

Medical device essential principles/GSPR software from Rimsys

Collaborative development
Collaborative development

Collaborate with your team to determine applicability, apply standards, and maintain your evidence of compliance

EDMS integration
EDMS integration

Connect to your document management, PLM, and quality systems to directly integrate information into your tables

PDF publishing
PDF publishing

Export completed tables and supporting documentation into consolidated PDF documents for simplified submissions

Bulk updating
Bulk updating

Automatically propagate record changes across multiple products and product families

Links to standards and change monitoring
Links to standards and change monitoring

Integrate automated standards management with your essential principles tables, and get notified of changes

EBOOK

The ultimate guide to the EU MDR general safety and performance requirements (GSPR)

Breaks down Medical Device EU MDR GSPRs into layman's terms, provides expert analysis and a comparison table of the EU MDD Annex I to the EU MDR Annex I.

The ultimate guide to the EU MDR general safety and performance requirements (GSPR)
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