With our support, the companies have always succeeded: all regulatory requirements are met, the FDA gives the green light, and product marketing can begin as quickly as possible.
We create your precise timetable, so you know exactly who has to do what and when. That means you can reliably plan your budgets and marketing and be sure you won't forget anything.
You communicate with one person who coordinates the entire project and ensures you don't create redundant QM or approval documents. That saves you time and money and increases your regulatory safety.
Request our free US Market Entry Compass to get an overview of the FDA requirements for quickly and safely launching your medical and IVD medical devices in the US market.
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We provide you with an experienced consultant as your personal contact who will accompany you throughout the entire project, coordinate the tasks to be completed, and involve the necessary experts at the right time to ensure that the project runs smoothly and in line with your goals.
Our experts will clarify the key questions with you right at the start:
Our FDA experts create product-specific documents for you, carry out gap analyses, and correct errors. We can take care of all documents on request, whether DHF, DMR, cover letters, or forms.
That means you have compliant approval documents in your hands that are specific to your device, the selected procedure, and the submission form, e.g., eSTAR. All you then have to do is submit them.
We ensure that
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We provide you with everything from a single source. This also applies if you do not yet have all the necessary evidence:
Targeted communication with the FDA almost always helps to clarify detailed questions and maximize the chances of obtaining authorization quickly and according to plan. We prepare these so-called “pre-submission meetings” together with you, help you answer any reviewer queries, and accompany you during the meeting. We also support you with requests for information in accordance with Article 513(g).
Even after the FDA successfully clears your device, you can count on us. We support you with the establishment registration and device listing and, if you wish, act as your US Agent. For this purpose, we use our Johner Institute North America subsidiary.
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Even if the FDA has already identified deviations or you have concerns, help is at hand. You can also rely on our support with remediation.
Contact us right away to make an appointment with one of our FDA experts and determine the first steps of your US market access.
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+49 7531 94500 20
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