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MEDEC Speaker Series - Europe's new Medical Device Regulation (MDR)
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The first major revision to device regulations since 2007

2016-09-29
When: Thursday, September 29, 2016
10:00 AM (EST) and 2:00 PM (EST)
Where: EMERGO Free Webinar
Canada
Contact: Katherine Cartlidge
416.641.2754

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europe's new medical device regulation (mdr)

THE FIRST MAJOR REVISION TO DEVICE REGULATIONS SINCE 2007


EMERGO Free Webinar - September 29, 2016

   Two sessions available:  10:00 am EST or 2:00 pm EST


 

Ronald Boumans

Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in the Netherlands)

The first major revision to device regulations since 2007 has been released and the changes are significant.  Although the MDR will not take effect for a few years this free webinar will help you plan ahead to liaise with the EU Notified Bodies.  The most important changes will be outlined, including:

  • How the MDR is organized
  • Scope of the legislation
  • Device classification rules
  • New clinical evaluation requirements
  • UDI and EUDAMED database
  • Adverse event reporting
  • And much more ...

For your convenience, this webinar is being conducted at two different times, 10:00 am and 2:00 pm (EST).  

REGISTER NOW for this event and find details for different time zones, by visiting:   http://www.emergogroup.com/resources/webinar-europe-mdr-changes

A printable flyer is also available here

 

WHO SHOULD ATTEND: Anyone involved in European medical device regulatory compliance.  This webinar will NOT cover the basics of CE Marking.  Attendees should have a solid understanding of CE and the current MDD to receive the most benefit.  Attendees will receive PDF copies of Emergo’s 15 page white paper detailing the coming changes in the MDR, plus a bonus paper on European post-market surveillance.


A webinar in respect of In Vitro Diagnostics Regulations has also been scheduled for November 9th, 2:00 pm EST and November 10th, 10:00 am EST.  

Details to follow shortly.

 


 

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MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our publicly-funded health care system. We are committed to supporting the growth of a strong and vibrant medical technology industry that contributes to Canada’s innovation economy.



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