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.
It is difficult to keep track of the large number of individual national laws, guidelines, standards, databases, and non-explicitly formulated requirements.
Many of these requirements are only available in the national language and are constantly changing.
Because these requirements are usually not coordinated, manufacturers run the risk of not meeting requirements or creating largely redundant documents, which not only increases the effort involved but also the regulatory risks.
Incorrect qualification or classification of the medical or IVD medical device, an inappropriate approval procedure, or incomplete documentation massively delays approval, driving up costs while further delaying the planned and required revenue.
Without references, it is difficult to find trustworthy regional partners and avoid the risk of documents falling into the wrong hands or even creating new competitors.
We compile the relevant laws, standards, and guidelines specifically for your devices and keep you updated on changes.
Learn more
We help you qualify and classify your devices, find the most suitable approval procedure, and create approval roadmaps.
Learn more
We ensure that you have all the necessary device and QM documents and that they meet the market-specific requirements.
Learn more
We define and research country-specific requirements for product testing and help you select suitable test laboratories with our international partners.
Learn more
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.
Learn more
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.
Phone
+49 7531 94500 20
Contact Form
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
