Home Events Getting started with your CE mark

29 oktober 2019, 16.00 - 20.00 uur

Getting started with your CE mark

TechMed Series 1/8

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. 

Course aim

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. 
 

For whom

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.

 

 The TechMed Centre, Technohal (Building 18)
University of Twente, Drienerlolaan 5; Route
€ 25,-
15.45 - 16.00 Registration 16.00 - 16.15 Presentation TechMed Centre 
16.15 - 16.30 Learn from the best: Holland Innovative & Panton 
16.30 - 17.30 Workshop part 1 (incl. interactive exercises and work on your case)
17.30 - 18.15 Meet & Eat: Sharing dinner
18.15 - 18.35 Lecture professor of the University of Twente
18.35 - 19.35 Workshop part 2 (incl. interactive exercises and work on your case)
19.35 - 19.45 Questions
19.45 - 20.00 Network drinks
LISETTE VAN STEINVOREN - STAMSNIJDER Sr. Project manager at Holland Innovative
MARIO DE ZEEUW Managing director - Panton

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University of Twente,  The TechMed Centre, Technohal (Building 18)
Drienerlolaan 5
7522 NB Enschede

Health Valley Partners