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Techmed Workshop NEW - Clinical validation Clinical validation for medical devices (towards CE)

THE WORKSHOP

Clinical validation for medical medical devices (towards CE).

In this workshop the following subjects will be handled:

  • Changes from MDD to MDR with respect to clinical evidence.
  • Device classification and routes to CE.
  • What are the different types of clinical evidence?
  • Performing a clinical trial: sponsor perspective.
  • Applying for a clinical trial: medical research ethics committee.
  • Investigational medical device dossier.
  • Documentation for CE.
  • Clinical evidence and documentation after market introduction.

COURSE AIM

During this workshop you will learn more about the regulatory background, but also about practical issues. A case study will be used for hands-on practice during the workshop. Main questions are:

  • What are the (new) requirements for clinical evidence according to the MDR?
  • What types of clinical evidence exist and how do you set up a clinical trial?
  • What documentation is needed for CE and after market introduction?

DETAILED OVERVIEW


16:00 - 16:15

Registration and coffee


16:15 - 16:30

Introduction medical device regulation and clinical validation

Holland Innovative


16:30 - 17:00

Case example

Roessing Research and Development

17:00 - 17:30

Clinical evidence

 

Demcon


17:30 - 18:15

Food


18.15 - 18.45

Clinical trial

University of Twente

18.45 - 19.15

Working with IMDD form

Roessing Research and Development

19.15 - 19.45

Documentation for CE certificate

Demcon

19.45 - 20.00

Questions, networking and drinks


FOR WHOM

It doesn’t matter in which stage you are with developing your medical device, this workshop is ideal for every entrepreneur, researcher or student. If you want to know, learn and apply clinical validation.

WHERE & WHEN 

  • 13 november 2018
  • 16:00-20:00
  • Carré 2.116
  • University of Twente, Drienerlolaan 5, Enschede

SPEAKER

UNIVERSITY OF TWENTE
CINDY LAMMERTINK
Clinical research coördinator

Within the TechMed Centre, research support is provided to University of Twente researchers performing studies in the clinical domain. Our expertise covers applicable legislation and guidelines, methodology and feasibility of clinical scientific research at the University of Twente.

ROESSINGH RESEACH AND DEVELOPMENT
LEENDERT SCHAAKE
Biomedical engineer

Roessingh Research and Development (RRD), the largest Dutch scientific research centre for rehabilitation technology, is an independent R&D organization linked to the Roessingh rehabilitation centre in Enschede, the Netherlands. RRD is internationally recognized as centre of excellence in the fields of rehabilitation technology and telemedicine. Furthermore, we cooperate closely with the University of Twente, where four of our senior researchers have scientific chairs.

Our expertise and projects cover a wide range of topics related to rehabilitation technology and telemedicine. Examples include robotics for treatment and support of the upper extremity, three dimensional ambulant gait analysis, online services to identify and prevent frailty among older adults, and display technology for integrating domotics to support independent living.

For a full overview of RRD’s expertise showcased by projects, please consult our website. RRD’s work is mainly funded through the granting network for care-related research, both at national and European levels.

 

HOLLAND INNOVATIVE
LISETTE VAN STEINVOREN
Sr. Project Manager

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. 

DEMCON
ESTHER SPANJER
Clinical research specialist

Demcon is a high-end technology supplier of products and systems, with high-tech, industrial systems & vision, optomechatronic, unmanned, embedded and medical systems as focus areas. Demcon is a business that supports clients with a wide range of competencies. As a system supplier, Demcon can meet the entire needs of its clients, from proof of principle, prototype and pre-production to serial production. Demcon is certified for ISO 9001:2015 and ISO 13485:2016.

REGISTRATION

We welcome a maximum number of 40 participants. Participation is free of charge. We will count on your participation for creating working groups and 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: TECHMED WORKSHOP SERIES 

Powered by: TechMed Centre - Holland Innovative - Roessingh Research and Development - Demcon.

This workshop is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. This one-year-course of workshops covers the most important, but also most challenging, topics required for the development and production of a safe, reliable and useful medical device. The workshops are organized for (future) entrepreneurs in the medical device industry, take place every 2 months on an afternoon and focus on one specific topic every session. It is possible to attend the complete course, but also separate workshops.

The TechMed Workhsop Series is part of the TechMed Proeftuin. By sharing their knowledge and expertise in the workshops series the TechMed Proeftuin partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction. The TechMed Proeftuin receives funding from the European Regional Development Fund (ERDF) of the European Union; the Workshop Series can therefore be offered free of charge.