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TechMed Series: Getting started with your CE mark - Session 1 of 8

THE NEW DATE FOR SESSION 1 IS 29 OCTOBER 2019
Register here

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. 

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. 

detailed overview

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

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.

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

Speakers

Lisette van Steinvoren - Stamsnijder
Sr. Project manager at Holland Innovative

Holland Innovative

New products need to be as reliable as possible, have the potential to the market quickly, and, above all, they need to meet the expectations and requirements of the customer. Holland Innovative is specialised in Project Management, Product and Process Development and Reliability Engineering. Customers include leading multinationals, Small and Medium Enterprises (SME's) and start-ups. They have a strong desire to do things differently - in a better way. Holland Innovative delivers excellence, experience, the power of implementation and, above all, flexible project managers and experts. 

Mario de Zeeuw
Managing director - Panton

Panton

Panton is a design studio for healthcare. With the help of design, we want to make health care more intuitive and effective. The care is complex; safe products and processes are desperately needed. there is a need for clarity. we like to think from and with the users. Our goal: thoughtful designs, inviting to use. We are convinced that care with design will become safer and, above all, more fun!

payment

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 techmed-events@utwente.nl

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. 

The TechMed Series is a spin-off from the TechMed Proeftuin, an initiative by Holland Innovative, Unitron, Panton and the University of Twente

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