FDA Medical Devices

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We are your trusted partner in the U.S., assisting you with FDA compliance of your medical devices. Learn more about our FDA agent and support services.

Based in New York, TABS is a trusted and proven U.S. partner, that can help you with the FDA compliance of the medical devices that you want to market in the U.S. We have already offered our high-quality FDA agent and support services related to product registration, facility registration, and label review for medical devices to many companies. 

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. We offer high-quality FDA agent and support services related to medical devices establishment registration, device listing, U.S. – Agent,  label review for medical devices, and assessment to help you look forward to successfully entering and navigating the U.S. market.

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Medical devices

Is your product a Medical Device?

It’s your product classified as Class 1?

I am not sure.

Yes, but I need to confirm its classification.

Yes, and I am a foreign establishment and I need an U.S.-Agent for registration and listing purposes.

We are your U.S. partner that helps with FDA compliance of medical devices

When you are interested in marketing your medical devices to the U.S., your product must be examined to determine if the device is regulated by the FDA as a medical device and to confirm the regulatory class that applies to your medical product before you can finish the registration. The safety of all regulated medical products is monitored by the FDA and the sale of medical device products in the U.S. is thus thoroughly regulated. 

Do the medical devices that you want to market in the U.S. meet all the laws and regulations that were established by the FDA? TABS is a U.S.-based expert on FDA compliance of medical devices. We offer our FDA agent and support services to companies in European countries that are looking to market their medical devices in the U.S. and expand their business abroad. We can assist you with the FDA registration of your medical device (or multiple devices), meeting the FDA requirements, and determining product classification, so you will be able to enter the U.S. market as a manufacturer from a foreign country. 

Our FDA Agent and support services

TABS offers FDA U.S. Agent and support services concerning registration and classification of medical devices from manufacturers from European countries that want to market medical devices in the U.S. and need assistance with compliance with FDA requirements: 

  • Medical devices assessment
  • Medical devices establishment registration, device listings, and U.S. agent services
  • Medical devices label review

Start marketing your medical devices to the U.S.

Would you like to receive professional assistance concerning FDA compliance and registration, so you will soon be able to market your medical devices in the U.S.? Our specialized FDA team is here to help you register the facility and list your devices. Contact us for more information or schedule a free 15-minute consultation call.

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