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Event NameECCRT 2012 Introduction to Clinical Research with Medical Devices
Event Date(s) Tuesday, October 02, 2012  to Tuesday, October 02, 2012
Event Location TBD
Brussels,
Belgium
Cost€ 850,00
DescriptionThis one day course is designed to introduce the fundamental concepts and regulatory requirements of clinical trials with medical devices.

Topics include definition and classification of different types of medical devices, introduction to medical device regulations in Europe and in the US, the medical devices directive and the current ISO 14155 standard. Contents and requirements of the investigator’s brochure and the investigational plan will be described.

Participants will learn about the implementation of the latest directives and MEDDEVS, ruling the pathway of CE marking. In addition, an overview of the European requirements regarding safety reporting will be presented.

SponsorN/A
Host CompanyN/A
Contact Information Phone: 32-0-2-464-39-55
Fax:   32-0-2-465-56-23 
Email: info@eccrt.com
More Information
 

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