When developing a medical device, clinical validation is mandatory and speaks for itself. However, what regulations are there for clinical evaluation? And how to set up clinical evaluation taking into account participants, researchers and experiments? Does the scale of the evaluation matter or not? This workshop will share practical examples in the set-up of clinical evaluation studies towards CE certification.
This knowledge is essential for everybody involved in or responsible for medical device development, both from a technology perspective as from a management perspective. Also it is relevant for everyone who is working on a medical device (prototype/product), such as engineers, researchers, projectleaders.
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