Benefit from our extensive expertise in all device classes. We ensure that communication with the FDA is professional and legally compliant.
Communicate with our experts in your time zone. No more late-night meetings or delayed responses.
Avoid risky dependencies on distributors. Stay flexible when choosing your distributors without jeopardizing your US market access.
Our large team ensures that a competent point of contact is always available for the FDA.
From product authorization and safety to post-market surveillance – we offer you all regulatory competencies from a single source.
Benefit from direct support from experienced experts in dealing with FDA inquiries and regulatory challenges.
As a manufacturer without a US subsidiary, you face particular challenges when selling your medical or IVD medical devices in the US market.
A lack of local presence, time zone differences, and dependence on distributors can lead to significant risks.
Inadequate communication with the FDA or an unavailable US Agent can, in the worst case, lead to market exclusion and jeopardize your US business.
Our US Agent service includes:
Contact us now to find out how we can support your success in the US market as your US Agent.
Phone
+49 7531 94500 20
Contact Form
We help you to bring your medical and IVD medical devices to market in the USA in just a few months using the 510(k) or De Novo procedure.
Our experts will help you to successfully pass FDA inspections and quickly remedy deviations.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
