New Life Science Webinar Hosted by Xtalks

How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead

Xtalks presents an exciting live webinar on Thursday May 23, 2013, at 11:00 a.m. EDT on how the medical device industry can prepare for upcoming EU regulatory changes. Keynote speakers Janette Benaddi, CEO, Medvance and Marcus Thornton, Senior Director, CTMS, Medidata Solutions, will examine the proposed changes and discuss what tools are available to support compliance.

On 26 September 2012, the European Commission announced the release of a draft revision to regulations that will impact medical device and medical diagnostic manufacturers in the EU and abroad. These revisions will bring stricter requirements for clinical trial evidence and demand greater data quality. Is your organization prepared to comply?

Topics include: 

  • Requirements for clinical evidence
  • Potential regulatory notification changes
  • The emphasis on post market clinical follow up
  • Class II devices and regulatory clinical investigations
  • Tools available to support quality and compliance

For more information about this event or to register click here.