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.
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.
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
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
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.
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
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
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
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 firstname.lastname@example.org.
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.
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