Peabody, Massachusetts.TÜV SÜD America Inc. announced that representatives of its global Medical Health Services Leadership Team will be presenting at The Revision of Europe’s Device Regulations: Navigating Uncertain Waters onMarch 17-18, 2014, hosted by the Washington, DC. office of Hogan Lovells. TÜV SÜD developed this program in collaboration with Innovative Publishing, LLC to foster collaboration and communication with medical device manufacturers on important upcoming changes in EU regulations and expectations.
TÜV SÜD clients are eligible for a 20% discount off the full conference rate. To take advantage of this offer, please use the code TUVSUD when providing payment.
Speakers from TÜV SÜD in conjunction with other medical device industry experts will present on the latest changes in the process for approval of medical devices in Europe-the first significant changes since the establishment of CE‑Marking for medical devices in the early 1990s. Another significant global initiative to be covered by the Medical Device Single Audit Program (MDSAP), which will be covered by the senior U.S. FDA official who is chairing the international MDSAP. At this conference, attendees will have an opportunity to provide input on the impact of planned changes on the industry.
TÜV SÜD’s senior management will provide presentations on several key topics, for example:
Kim Trautman, FDA’s Associate Director for International Affairs and Chair of the MDSAP Committee in the International Medical Device Regulators Forum, will provide details on this initiative including the upcoming MDSAP pilot program.
Other presentations will describe the impact of these changes on contractual provisions for manufacturers and their suppliers, and there will be a session on how manufacturers can prepare for unannounced audits.
To view the full conference agenda, or to register, click here.
Visit http://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices for details on Medical services available from TÜV SÜD America.
For more information, contact:
Vice President, MHS
TÜV SÜD America Inc.
For editorial information, contact:
Lisa Van Dorpe
Brand and Marketing Associate
TÜV SÜD America Inc.
About TÜV SÜD America Inc.
TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG, is a leading globally recognized testing and certification organization. TÜV SÜD's Product Service Division offers international safety testing and certification services. With over 600 experts in North America, TÜV SÜD America provides NRTL and SCC Certification, CB Scheme Certification, Field Evaluations, SEMI Evaluations, and other Industrial Machinery Services. Additional services include Restricted Substances Testing, CE Marking assistance, International Compliance, EMC/Environmental Testing, and Quality Management System Certification. TÜV SÜD also provides CE Marking assistance for the European market, Electromagnetic Compatibility (EMC), Electrical & Mechanical testing, and many additional global conformity assessment services that help companies gain product compliance in order to enter individual country markets. For more information, visit www.tuv-sud-america.com.
About TÜV SÜD
TÜV SÜD is a leading international service organization catering to the business segments INDUSTRY, MOBILITY, and CERTIFICATION. It is a leading one-stop global solution provider for product quality and safety testing & inspections, engineering support, management system certification, and training solutions. With over 17,000 employees, TÜV SÜD operates worldwide at more than 800 locations. As partners in our customers' processes, our specialist teams ensure that technology, systems, and know-how are optimized, thus strengthening our customers' global competitiveness. More information is available at www.tuv-sud.com.