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With our support, the companies have always succeeded: All regulatory requirements are met, the authorities give the green light, and product marketing can begin as quickly as possible.
We create your precise timetable so you know who has to do what and when. This means you can reliably plan your budgets and marketing and be sure you won't forget anything.
We coordinate your global approval projects and ensure you don't create redundant documents. This saves you time and money and increases your regulatory safety.
We compile the relevant laws, standards, and guidelines specifically for your devices and keep you updated on changes.
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We help you qualify and classify your devices, find the most suitable approval procedure, and create approval roadmaps.
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We ensure that you have all the necessary device and QM documents and that they meet the market-specific requirements.
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We define and research country-specific requirements for product testing and help you select suitable test laboratories with our international partners.
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We help you register your devices and company in the national databases and communicate with the authorities.
We can find national representatives for you or take on this role ourselves.
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Contact us right away to clarify initial questions about country-specific requirements, plan the first steps of your international approval, and determine the duration and costs of the project.
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+1 (240) 638 27 09
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