Staying out of the EU market is not an option for any medical products company.
Approval does not have to be a problem, either. If you are already certified to ISO 9000:2000 we can show you how to clear the regulatory hurdles without pain, and
it is even easier if you already have your ISO 13485:2003. If you aren't that far along,
we can help you achieve ISO certification and then get both EU and USA approvals in one step.

We integrate the logistics, the distributions, and the creation of the sales channel into a single strategic service. Our operations experts know how to optimize site selection, shipping, and distribution.

What We Do

Maybe you just need some advice, or a review of your files and systems. We do that. Maybe you are considering a new product and want a complete EU regulatory and
sales plan. We do that too. Or maybe you just need someone to connect you with good distributors and set up efficient logistics. We do that too.

Our experts have handled scores of Class II and Class III products, with timely approvals, effective logistics, short timelines, and profitable contracts with capable independent sales representatives. Every situation is different in some ways, but we can show you a short path to European Market profits.