Regulatory Consulting for Medical Devices

A medical device’s path to market is not a straight line.

Regulatory strategies and submissions present one set of choices after another. Even those that avoid pitfalls may take you on unnecessary detours… and there are no shortcuts.

But some routes are faster and surer than others.

We live on these trails. We’ve crossed this terrain with companies large and small. We have trained to be your regulatory pathfinders, helping you bring your device to market with efficiency and integrity.

The path to market leads ultimately to the patient, whose well-being is a sacred trust.

Our twofold mission:

• First, to help companies bring safe and effective new medical devices to patients as soon as possible;

• Second, to help companies keep safe and effective medical devices on the market for as long as patients need them.

Whether you’re developing a new product that advances the state of the art, or maintaining one that has served patients well for years, we’re here to help you, because you help all of us.

Like you, we’re at home in the lab and the library, the cleanroom and the clinic, the back office and the boardroom.

We’re based outside Washington, D.C., after more than a decade in the med-tech centers of Orange County, California and Minnesota’s Twin Cities. Now a short drive from Silver Spring and a train ride from Capitol Hill, we track what’s happening and watch for what’s coming at FDA, in Congress, across the United States, and around the world.

We specialize in supporting Class III implantable devices in the U.S. and E.U., but we’re interested in everything. If you have a medical device you believe in, we want to hear from you.

Ready to get going?

Let’s map out your path.