Mapping Your Success: Changing Regulatory Requirements and the Impact on Achieving and Maintaining CE Marking

Friday, September 20 2013
7:30 am – 4:45 pm

Location: Boston Marriott Newton, 2345 Commonwealth Ave, Newton, MA

The Healthcare Solutions experts at BSI, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union, are offering members of the medical device community exclusive access to global industry experts at three roadshow events in key U.S. cities in September.

“Now in its second year, the BSI Roadshow provides the most meaningful, up-to-date, and relevant regulatory and compliance information to the medical device industry,” said Paul Brooks, Senior Vice President for BSI Healthcare Solutions. “Building on last year’s successful events, our global experts will gather in person once again with industry professionals to review in detail the ongoing changes to the regulatory environment in Europe. Our presenters have an average of 20 years of industry and regulatory experience—many of them holding patents in their respective fields. We are looking forward to responding in person to questions from each participant, giving them the insight they need to perform their various roles.”

The event, open to the medical device field, will engage the audience regarding the importance of entering today's European market and preparing for the expectations and changes in the future. The event will take place from 7:30 a.m. to 4:45 p.m. local time in each of the following cities:

  • Sheraton Palo Alto, Palo Alto, CA – Monday, September 16, 2013
  • Sheraton Minneapolis West, Minnetonka, MN – Wednesday, September 18, 2013
  • Marriott Boston Newton, Newton, MA – Friday, September 20, 2013

The roadshow, titled “Mapping Your Success: Changing Regulatory Requirements and the Impact on Achieving and Maintaining CE Marking,” will feature prominent industry experts from BSI Healthcare Solutions:

  • Global Director of Medical Technologies, Gary Slack
  • Senior Vice President of Healthcare, Paul Brooks
  • Director of Operations and Delivery, Neil Adams
  • Technical Director, Dr. Ibim Tariah, PhD
  • Head of Training and Operations, Suzanne Halliday
  • Product Experts Laurel Macomber and Gregory Martin
  • Product Manager for GRC Solutions BSI Group America Inc., Raj Sivasankar

The following topics will be discussed with an open Q&A session:

  • Changing and Evolving Requirements for CE Marking
  • Top Non-Conformities Requiring a CAPA Process
  • Staying Current on Standards Under the EU Approach
  • Understanding Clinical Equivalence
  • Risk Management and the Impact of Annex Z
  • Mobile Health: Software, Mobile Phones and Telemedicine Under the EU Approach
  • Animal Tissue: Update on Latest Animal Derived Material Requirement
  • Guidance on Acceptance of E-Labeling Under the EU Approach
  • Brussels Update on Proposed Medical Device and IVD Regulations

Events in each location will include opportunities for networking and time for Q&A with the experts. Additional information regarding venues and topic details are available at the event registration page, located online at http://www.bsiroadshow.com

For more information about these events or upcoming white paper releases, webinars and training opportunities surrounding the European medical device market and related regulations, please visit http://medicaldevices.bsigroup.com or call 800-862-4977.

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