Making the difference
29 oktober 2019, 16.00 - 20.00 uur
Getting your CE Mark is certainly not something you would do on a Friday afternoon but is often underestimated, especially now the regulations have been updated to the MDR. You need a.o. to test the product; by official test houses on legal standards, build up a technical construction dossier, have a quality management system, with approved suppliers and implemented of risk assessments by proven competent team members. Most of these requirements however, could be prepared very early on during the development of a medical device, and makes the CE marking process later on much easier.
This training provides you with a starting point of what is changed due to the introduction of the Medical Device Regulation, what required for CE marking and Quality Management.
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.
University of Twente, The TechMed Centre, Technohal (Building 18)
7522 NB Enschede
Naar onze partners
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