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Free MDR + IVDR Gap Analysis Toolkit

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.

MDR Gap Analysis Tool

 
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

This free toolkit includes the trial versions of these tools. The full version, including all chapter requirements and more, is available for purchase by clicking here.

WATCH THIS 2 MINUTE OVERVIEW VIDEO TO SEE THESE TOOLS IN ACTION →

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ABOUT GREENLIGHT GURU
 
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Click here to learn more.
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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 our website to learn more by clicking here.