Our Story
Regulations have a real purpose.
Ensuring the quality and safety of products is vital. This is especially true for medical devices, where a failure can easily lead to serious harm to the patient, or even death.
However, meeting the various requirements, regulations and standards across the globe is complicated, time-consuming and expensive.
That’s where MDRG come in.
Our experienced team came together with a mission to make it easier for medical device companies to meet regulatory requirements and pass audits.
We have a combined experience of over 40 years in the medical device industry, with an especially strong background in regulatory affairs. We know how difficult and time-consuming it is to meet regulatory requirements, be it the EU, FDA, or national standards, and we are here to ease your journey.
We did the hard work, so you don’t have to.
All our tools were designed from the ground up to meet specific regulatory needs, with 1000s of hours spent on their development, refinement, and in-the-field testing.
Please take your time to review them in our shop, we’re sure you’ll find them useful, and best of luck on your compliance journey.