US Agent
Professional US Agent service for (IVD) medical device manufacturers
Highest Level of Regulatory Competence
Benefit from our extensive expertise in all device classes. We ensure that communication with the FDA is professional and legally compliant.
No Time Zone Issues for European Manufacturers
Communicate with our experts in your time zone. No more late-night meetings or delayed responses.
Independence from Distributors
Avoid risky dependencies on your distributors. Stay flexible when choosing your distributors without jeopardizing your access to the US market.
Guaranteed Reachability
Our large team ensures that a competent point of contact is always available for the FDA.
Comprehensive Expertise
From product authorization and safety to post-market surveillance – we offer you all regulatory competencies from a single source.
Fast Problem Solving
Benefit from direct support from experienced experts in dealing with FDA inquiries and regulatory challenges.
A competent and reliable partner for legally compliant FDA communication
As a medical device or IVD medical device manufacturer without a US subsidiary, you face particular challenges when selling your 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.
We take on the legally required role of the US Agent and ensure market access for your medical devices in the USA
Our US Agent service includes:
- Taking over and ensuring communication with the FDA
- Professional support in registering companies and devices
- Professional support in solving regulatory issues
- Contact persons in the European time zone
- Guaranteed reachability through a large team of experts
- Independent and reliable partnership
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