Your Global Medical Device Regulations Guide

Tools, templates, and training to simplify the certification of your products worldwide

Our Mission

Medical Experts

Medical Experts

The idea for this grew out of personal experiences working with medical device regulations and understanding how complex, time-consuming, and risky it can be.

We created MDRG specifically to provide simple, easy-to-use tools and templates that you can apply right away.

Let us help you get your products to market - saving you time, money, and hassle in the process.

We have spent thousands of hours developing tools to help your ISO 13485, MDR, IVDR, MDSAP journey.

Check them out in our shop

Medical Device Regulation (MDR)

Check out our quick overview and preparation guide.

Medical Device Single Audit Program (MDSAP)

Visit our overview page to learn more.

In-Vitro Diagnostic Regulation (IVDR)

Read our guide now to ensure you are ready ahead of time.