Legislators and authorities demand a lot before they grant permission to use medical procedures and products in human beings, and they are right to do so. In addition, market entry alwas takes the way through successful clinical studies. Start-ups and newcomers to the medical technology market risk getting lost in the jungle of directives, standards and regulations and quite a few good ideas have already failed because of this hurdle.
It is better to keep an eye on regulatory requirements from the very beginning, as they are already taking effect in the development process. With our experience and know-how, we accompany you through the documentation of your project, your clinical studies, support you with applications and impart knowledge and contacts.
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