Press release - Reston, VA - August 1, 2012
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 unprecedented access to global industry experts at three roadshow events in key U.S. cities in September.
“The BSI Roadshow promises to be a premier event for the medical device community in 2012,” said Paul Brooks, Senior Vice President for BSI Healthcare Solutions. “It is the first time our global experts will gather in person with industry professionals to review in detail the nuances of a European medical product launch. We are looking forward to three very exciting events.”
The complimentary, exclusive event will engage the audience around the importance of entering today's European market and preparing for the expectations and changes in the future. The event will take place in the following cities:
- Cypress Hotel, Cupertino, CA – Thursday, September 20, 2012.
- The Marquette Hotel, Minneapolis, MN – Tuesday, September 25, 2012.
- The Fairmont Copley Plaza, Boston, MA – Thursday, September 27, 2012.
The roadshow, titled “Managing Today's Regulatory and Compliance Expectations,” will feature prominent industry experts—including Paul Brooks, Senior Vice President Healthcare Solutions; Gary Slack, BSI Medical Devices Global Director; Ibim Tariah, BSI Healthcare Solutions Technical Director, Suzanne Halliday, BSI Head of Healthcare Solutions Training and Operations; Amanda Brewster, BSI Manager of Software Services; and Mattias Kyhlstedt, Founder and CEO of Synergus—who will be on hand to discuss the following topics:
- The importance of the market, acceptance of innovation, and predictability of the regulatory process.
- Meeting changing and increasing clinical data requirements.
- Best practices in planning for reimbursement in Europe.
- Best practices for enhanced post-market surveillance.
- Using technology to maximize quality management system (QMS) requirements.
- Update on changes to European regulations affecting Medical Device Directives: setting future regulatory expectations.
Events in each city will include opportunities for networking and time for Q&A with the experts. A continental breakfast, refreshments and lunch will be provided at no cost to participants.
For more information about these events or upcoming white paper releases and training opportunities surrounding the European medical device market and related regulations, please visit the BSI Medical Devices Website or call 800-862-4977.