Our global regulatory affairs experts guide you through the jungle of directives, regulations and guidelines in order to meet national requirements of your key markets (e.g. Europe, United States, Canada and Brazil).
Usually, there is more than one way to obtain medical device registration in a country. There are many dependencies and factors that might open other, faster pathways to market access. As your competent partner we can develop a regulatory strategy to achieve the most efficient access to your market, either for a certain country or on a global level order.
Depending on the market the content of the submission documents varies in terms of form/structure, focus and content (e.g. STED, 510(k)). Our experts can provide background of regulations in your key market and help you identifying what is needed to complete your submission documents.
In order to obtain a successful registration, it is essentail that the submission documents are complete and fulfill all the requirements. Soundness and comprehensibility are key factors. Our experts support you in the compilation of submission documents, meeting all requirements.
The world of regulations changes more often and faster than it first might look like. Therefore it is crucial for manufacturers to be well prepared in order to be compliant. At knoell, we can provide you with the latest information on regulations and help you fulfilling all relevant requirements.
Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!