BSI Offers Medical Device Manufacturers Exclusive Access to Global Panel of Experts in 3 Key Cities Leading Notified Body Invites Medical Device Community to Gather and Discuss Updates to Changing Regulatory Environment in Europe
RESTON, Va., Aug. 14, 2012 /PRNewswire/ -- 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.
BSI is the world's first national standards body partnering with medical device manufacturers to provide impartial third-party standards based assurance, compliance, information solutions, and training. Backed by 80,000 client locations in over 100 countries, and more than 50 BSI offices, we are the trusted partner of Industry and Government professionals all over the world.
The Support of an Industry-Leading Medical Device Team
BSI is an approved "full scope" Notified Body, recognized by the European Commission. Every day, we work with our customers to deliver on our global mission: to ensure patient safety while supporting timely access to medical device technology.
Expertly Driven Partnerships
BSI combines an expert understanding of local and regional medical device regulatory issues with the efficiency and cost-effectiveness of a global network of industry resources. By partnering with BSI, our customers can count on more than just technical capabilities and testing capacity. We build long-term working relationships to identify challenges and create solutions that meet each customer's unique needs.
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