Wednesday, May 24, 2023

4:15 PM - 5:30 PM

Room L2

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Details

What do you need to do to get a product to market as quickly as possible? What are the strategic, commercial, clinical and regulatory factors you need to consider? The panel will take you on a whistle stop tour to consider the strategic and commercial elements of clinical data collection and evidence generation, the regulatory considerations in light of a changing landscape and to consider how to execute your clinical trial efficiently and effectively. In both the US and the EU there is a growing need for medical devices to undergo a clinical trial before they can be placed on the market. Whilst it is almost self-evident that a clinical trial is a systematic assessment of the device’s safety and/or efficacy in human participants, it presents another hurdle to overcome in order to get regulatory clearance. This is particularly true for the EU, where all Class III and Class IIb implantable devices must undergo clinical investigations according to EU MDR. The requirements in the US are no less complex but are better understood. There is also an increased emphasis on post marketing surveillance, which may be a whole new world for many companies.

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Speaker