These free tools are intended to help manufacturers begin the transition to Europe's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) by understanding and assessing which changes must be made to comply with chapter I requirements.

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What's Included in this Toolkit

MDR Gap Analysis Tool

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This trial version of the tool will help you:

  • Understand, assess, and implement with applicable requirements from chapter I of the MDR

  • Identify gap areas to update for compliance chapter I requirements

  • Customize your analysis based on the specific functions within your organization

IVDR Gap Analysis Tool


This trial version of the tool will help you:

  • Begin your transition to compliance with an assessment table of chapter I requirements from IVDR

  • Identify and connect chapter I requirements with the processes and persons/departments responsible

  • Save time with unique keyword search functions

Download the free toolkit now!


About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.


About Regulatory Globe

Health is one of the basic needs of humans and should always come first. People who cannot cover these basic needs, for whatever reason, are usually dependent on outside help and that is precisely the goal of the medical technology industry. To develop medical products that improve quality of life and extend life expectancy.

In order to serve this basic need optimally, laws and regulations are inevitable. Such regulations ensure safety and quality of products as well as raise the state of the art and thus promote progress steadily. This is the reason why it is so important to take the new requirements as an opportunity for improvements and not as a burden. Only companies that recognize this will be successful in the long term.

This is where the task of Regulatory Globe begins. Together with our partners, we specialize in monitoring laws and regulations and provide tools that help our clients improve their products processes. This will eventually benefit the people in need of these medical devices.

Visit their website to learn more by clicking here.

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