Our Story
Regulations exist for a reason—especially in the medical device world.
Lives are on the line, and quality and safety can't be compromised. But navigating global requirements—whether it’s EU MDR, FDA, or country-specific standards—is complex, time-consuming, and costly.
That’s where MDRG comes in.
Our experienced team came together with a mission to make it easier for medical device companies to meet regulatory requirements and pass audits.
With over 40 years of combined experience in regulatory affairs and the medical device industry, we’ve lived the pain of compliance—and we’ve built tools to solve it. Our mission is simple: make passing audits and meeting regulatory requirements easier.
We’ve done the hard work—so you can focus on innovation.
We’ve spent thousands of hours designing, testing, and refining practical, ready-to-use solutions—so you don’t have to start from scratch.
Browse our shop and see how we can help you take the stress out of compliance.