Helping you navigate the world of medical device regulation

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How RegMetrics can help you

RegMetrics helps you navigate the world of medical device regulation.

Classify your medical device efficiently

Our wizard walks you through a set of straightforward 'yes' or 'no' questions to find out the anticipated classification for your medical device according to the EU MDR/ IVDR

Identify your safety and performance requirements

The RegMetrics algorithm will help you identify the General Safety and Performance requirements for your medical device according to the EU MDR/ IVDR

Retrieve your specific standards and relevant test houses

RegMetrics will provide you with suggested standards specific for your device and test centres that can help you test your devices according to the requirements

Hear it from our users

RegMetrics is helpful when scoping grant submission activities, de-risking the proposal and ensuring sufficient budgetary requirements. RegMetrics also helped us with our regulatory strategy and I would recommend using the tool.

Clark Crawford

West Midlands Academic Health Science Network, UK

I have spent thousands of dollars on regulatory advice and I did not understand any of it, just with this [training] session and using RegMetrics, I understand it much better.

MedTech innovator

RegMetrics is the only tool that tells you what class of medical device you are working on and why. The "why" is very helpful for founders, as it gives them confidence and insight into medical device classification.

Dr. Bodo Brückner

Life Science Accelerator Baden-Württemberg, Germany