Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.

Free IVDR Gap Assessment Tool

A simplified way to identify your quality and regulatory gaps.

A free tool to help medical device companies streamline the transition process to the new EU IVDR. Using an easy and straight-forward method, manufacturers of in vitro diagnostic devices can understand, assess and execute the necessary changes for compliance.

Free Version Includes:

1.   IVDR Gap Assessment Tool
    • Assessment table of chapter I requirements
    • Connect requirements with
      processes and responsible departments/persons
    • Unique keyword search functions
2.   Instructions for Use of Tool
    • How-to guide on using and leveraging the tool
    • Step-by-step guidance on tool functionality
    • Visual aids that walk you through various tool functionalities

gg-rg-2-tool-icons

To download the full, paid version of this tool, click here.

Free IVDR
Gap Assessment Tool

SUBMIT THIS FORM for INSTANT ACCESS TO THe FREE CUSTOMIZABLE  TOOL and Instructions for use!

gg-rg-2-tool-icons

 

These free tools have been developed by our partners at Regulatory Globe. If you're interested in downloading the full paid version, click here.

If you have any questions regarding the content of these tools, please contact the developer, Michael Galliker at Regulatory Globe.

Yes, I Want This Free Download!

Logo_Rglobe_300dpi
 
ABOUT REGULATORY GLOBE
 

Health is one of the basic needs of humans and should always come first. People who cannot cover these basic needs 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, laws and regulations are inevitable. Regulations ensure safety and quality of products as well as raise the state of the art and thus promote progress steadily. This is why it is important to approach new requirements as an opportunity for improvements, not as a burden. 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 and processes, and benefit the people in need of these medical devices. Visit our website to learn more by clicking here.

green-lockup-1

 

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.