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.
1. IVDR Gap Assessment Tool
2. Instructions for Use of Tool
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.
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.