Multi-market entry | FDA and EU requirements for clinical investigations of medical devices
March
23

Multi-market entry | FDA and EU requirements for clinical investigations of medical devices

 March 23, 2023 

Online


For manufacturers of medical devices, it is strategically advantageous to consider the regulatory and market access requirements of different systems, such as in the EU or the USA, at the beginning of the development of new products in order to save costs. In addition, there are different requirements within the EU at the level of the member states. In the first part of the workshop, small and medium-sized companies from the diagnostics industry will learn about the differences between the regulatory requirements of the US and EU systems when it comes to clinical testing of medical devices, such as diagnostics. Amko Groeneveld (novineon CRO GmbH) will provide step-by-step guidance through the requirements for generating clinical data, identifying and navigating FDA sources, and using available information.

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