session 1: GETTING STARTED WITH your CE MARK
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.
15.45 - 16.00
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
19.45 - 20.00
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.
when & WHERE
- 29 October 2019
- 16.00 - 20.00 (registration from 15.45)
- Entrance: € 25,- (incl VAT) per person <-- NORMAL TICKET IS € 30,-
- Language: English
- Location: The TechMed Centre, Technohal (Building 18)
University of Twente, Drienerlolaan 5; Route
The entrance for this event is € 25,- (incl. VAT) per person (a first edition discount of € 5,-). You can already register for this event, but at the moment we don't have set up our digital payment system. Therefore, we send you around 1 or 2 weeks before the event, a link to the payment system. We kindly ask you to pay before the start of the event.
registration & cancelation
We welcome a maximum number 50 participants. We will count on your participation for creating working groups and the catering. If you cannot attend the event for which you have already registered, we kindly ask that you let usknow. Simply e-mail email@example.com.
TECHMED SERIES: 8 SESSIONS
The TechMed Series "Remove the barriers to market readiness" is a one-year-course of workshops for (future) entrepreneurs and scientists in medical technology. The series covers the most important, but also most challenging topics required for the development and production of a safe, reliable and useful medical devices. Following the successes of the past years, we have updated the program to fit your needs on the road to market readiness. During the course of 1 year, 8 sessions are organized, taking place every month on an afternoon and focusing on one specific topic every session. During the sessions, you will work in groups to bring new knowledge to the test. There are no oblications, but we highly encourage you to bring your own case into the discussion! It is possible to attend the complete course, but also separate sessions.
ALL SESSIONS INCLUDES:
- Introduction by TechMed Centre.
- Learn from the best pitches: Participants can present their idea/struggle/product to the experts and they will give feedback.
- Lectures about the subject by the TechMed partners (Holland Innovative, Panton and Unitron) & 1 University of Twente lector.
- Workshop with different (inter)active exercises and working on your own case.
- Meet & Eat: Dinner & Drinks.
organization & partners
This session is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. The events are organized for (future) entrepreneurs in the medical device industry, take place every month on an afternoon and focus on one specific topic every session. By sharing their knowledge and expertise in the TechMed Series the partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction.
THIS EVENT IS POWERED BY: