Medical Device UDI Software

The first and only medical device UDI software built specifically for the MedTech industry that is fully integrated and automated to a product's registration lifecycle.

Medical device UDI data should never be independent of a product's registration lifecycle. A product is never static in the market, so why is your UDI data? UDI for medical devices is critically important to capture and maintain in an automated way to ensure changing regulatory information is properly captured and registered within the government UDI databases.

Welcome to the modern and automated way of maintaining your global UDI data.

Unique Device Identification (UDI) is a major global harmonization effort for more consistent data that benefits overall product traceability throughout the medical device supply chain.

 

Markets are rolling out medical device UDI requirements, such as the USA FDA UDI (GUDID), EU MDR/IVDR UDI (EUDAMED), China NMPA UDI, and many more.  Unfortunately, managing these independent systems with unique data sources from global markets has become problematic for all medical device manufacturers.

  • Automated medical device UDI updates as product registrations change
  • EUDAMED, GUDID and ROW Compliant
  • Fully integrated into your existing PLM/ERP system

The most advanced, automated, and fully integrated medical device UDI software on the market

UDI Software

How Rimsys Helps Medical Device UDI Requirements

Automatic UDI Maintenance. See for yourself how we are changing the game.

Step 1

Create, upload, and/or integrate UDI from existing systems into Rimsys

A holistic solution that manages regulatory, UDI, product and registrations data.

Step 2

Market specific medical device UDI systems

EU MDR/IVDR UDI (Basic UDI, Packaging UDI, Product UDI), USA FDA UDI, China NMPA UDI and more!

Step 3

Adaptable software for the changing regulatory landscape

As new markets roll out UDI requirements, Rimsys will be right there with you. Rimsys is adaptable and uniquely positioned to meet the needs of the MedTech industry.

Step 4

Enjoy automatic updates to UDI data

Rimsys is a holistic solution and our UDI software integrates seamlessly with our Product Registrations module. As you register products, UDI information is automatically updated, such as member states expiry dates, notified bodies, and device classifications!

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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.