One question device manufactures may ask is “which country is the best place in Europe to conduct clinical investigations for medical devices?” After realizing there could be so many scenarios and possibilities, the next question would be, “in which country can we start the study the fastest?”
There are numerous challenges to overcome including if the protocol is approved in one country and not in the other. Different countries may have different standards on data protection and X-ray follow-up. These should be taken into account already during the protocol development process. Other factors include gaining approval from ethics committees and submission process, fees and timelines. To get past these challenges, one must take all of these challenges and lay out the best strategies for the devices in the target countries.
NAMSA clinical expert, Celina Wang, will be discussing how to overcome these challenges and create the best strategy during her presentation at the Clinical Evaluations and Investigation for Medical Device Conference. You can schedule a meeting with Celina by contacting us.
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