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TechMed Series: Clinical evaluation of your medical devices - Session 5 of 8

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TechMed Series Remove the barriers to market readiness

the workshop

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.

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 programme

programme overview


15.45 - 16.00

Registration & coffee

16.00 - 16.10

Introduction of the TechMed Centre

16.10 - 16.15

Status development and Q & A 

16.15 - 17.00

WORKSHOP PART 1
by Mario Steel - Unitron Group

MDR with focus on clinical evaluation and technical documents in which the intended use / clinical performance and risk management are important input for clinical evaluation and that obtaining a CE mark is not a matter of just going to the counter. 

17.00 - 17.30

TechMed Talk 
by Prof.dr.ir. Ruud Verdaasdonk - University of Twente

Describing cases emphasizing the importance of pre-clinical evidence in relation to the clinical trial. 

17.30 - 18.00

Meet & Eat

18.00 - 18.45

WORKSHOP PART 2:  Clinical Trial: How to prepare and submit a METC dossier.
Cindy Lammertink - University of Twente

The procedures entailed in the development and market introduction of a medical device ask for clinical evidence. Quite often a clinical trial is necessary to provide this evidence, however clinical trials cannot be executed before a Medical Research Ethics Committee had approved the dossier of the trial. This presentation will cover all aspects of the preparation and submission of such a METC dossier

18.45 - 19.45

CASE ASSIGNMENT

In groups the attendees will work on a their own cases. After that they present their answers followed by a discussion and tips of the organization. 

19.45 - 20.15

End & drinks

speakers

Mario Steel
Production and Technical Service Manager - Unitron Group

Unitron develops and manufactures complete products, such as medical equipment and specific industrial products. This may involve the realisation of a completely new concept, but also the modification and optimisation of existing products.

This, in combination with our experience and business strenth, will result in a complete business concept. Unitron is active in several markets throughout the world. 

Drs. Cindy Lammertink Clinical Research Coordinator at University of Twente

Cindy Lammertink received her MSc (1996) in Biomedical Health Sciences from the Radboud University Nijmegen and worked as a researcher in several rehabilitation centers. She shifted her scope towards supporting UT researchers in legislative and ethical issues within research involving human subjects. She also advises the TechMed Centre in developing procedures and facilities for researchers. As part of this shift, she was an auditor at the local medical ethics research committee (METC Twente) for 5 years.

In 2015 she joined the Health Technology Assessment and Services Research group as a lecturer. She introduces students in the bachelor programs of Technical Medicine and Health Sciences into the field of Clinical Epidemiology.

Prof.dr.ir. Ruud Verdaasdonk
Professor at University of Twente

Rudolf M Verdaasdonk is full professor of Health Technology Implementation at the TechMed Centre and staff member the Biomedical Photonics Imaging group at the University of Twente. Before, he was head and chair of the department of Physics and Medical Technology at the Amsterdam University Medical Center (VUmc). He received his MSc in Applied Physics at the Technical University Eindhoven in 1985 and his PhD in Medicine at the University Medical Center Utrecht in 1990. He has been working in University Medical Centers for over 30 years as a registered Clinical Physicist.

practical information

When & Where

  • 3 March 2020
  • 16.00 - 20.00 (registration from 15.45; drinks after 20.00)
  • Entrance: € 30,- (incl VAT) per person
  • Language: English
  • Location: The TechMed Centre, Technohal (Building 18) - Room TL 2148
    University of Twente, Drienerlolaan 5; Route

registration & cancelation

We welcome a maximum number 30 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 us know. Simply e-mail techmed-events@utwente.nl

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. 

More information about the
TechMed Series

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

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